FDA/CFSAN 2000 FDA Procedures for Standardization and Certification of Retail Food Inspection/Training Officers: Annex 2-1 FDA Standardization Inspection Report

FDA Standardization Inspection Report

Establishment Name:

Type of Facility:

Physical Address:

Person in Charge:

City:

State:

Zip:

County:

Inspection Time In:

Inspection Time Out:

Date:

Candidate's Name:

Agency:

Standard's Name:

Indicate Person Filling Out Form: (circle one)

Candidate's Form / Standard's Form

Cold Holding Requirement for Jurisdiction: [5 °C (41 °F)_____] or [ 7 °C (45 °F)_____ ] or

[ 5 °C (41 °F) and 7 °C (45 °F) combination:______]

**Association between CDC-Identified Risk Factors and Food Code Interventions**
Food Code Interventions	Positive Association	Risk Factors
1. Demonstration of knowledge
2. Hands as a vehicle of contamination	YES	Poor personal hygiene
3. Employee health
4. Time/Temperature relationships	YES	Inadequate cooking Improper holding temperatures
5. Consumer advisory
		Unsafe food sources
		Contaminated equipment

Association between CDC-Identified Risk Factors and Food Code Interventions

Food Code Interventions

Positive Association

Risk Factors

1. Demonstration of knowledge

2. Hands as a vehicle of contamination

YES

Poor personal hygiene

3. Employee health

4. Time/Temperature relationships

YES

Inadequate cooking
Improper holding temperatures

5. Consumer advisory

Unsafe food sources

Contaminated equipment

For each item, indicate one of the following for OBSERVATIONAL STATUS: IN - Item found in compliance; OUT - Item found out of compliance; N.O. - Not observed; N.A. - Not applicable

The Standard may mark an item "S" to reflect a disagreement in a case where the Candidate has the opportunity to make an observation or take a measurement and fails to do so, and intervention by the Standard would alert the Candidate to the missed opportunity.

**FOODBORNE ILLNESS INTERVENTIONS AND RISK FACTORS**
*Indicates critical items
STATUS
	1.	DEMONSTRATION OF KNOWLEDGE
IN&OUT		Code compliance, certified via testing with accredited program, or responses to safety questions regarding operation*
	2.	EMPLOYEE HEALTH
IN&OUT	A.	Management awareness and policy regarding handling employee health situations*
IN&OUT	B.	Visible or known symptoms / or known diagnosis dealt with according to Food Code*
	3.	CONSUMER ADVISORY*
IN&OUT&NA		Inform consumers about the increased risk associated with especially vulnerable consumers when eating animal foods in raw or undercooked form via disclosure and reminder.
	4.	FOOD FROM APPROVED SOURCE
IN&OUT	A.	All food from regulated food processing plants / no home prepared or canned foods*
IN&OUT&NA	B.	All shellfish from NSSP listed sources / no recreationally caught shellfish received or sold*
IN&OUT&NA NO	C.	Game and wild mushrooms approved by regulatory authority*
IN&OUT	D.	Food received at proper temperatures / protected from contamination during transportation and receiving / safe and unadulterated food*
IN&OUT&NA NO	E.	Shellstock tags retained for 90 days from the date the container is emptied*
IN&OUT&NA NO	F.	Written documentation of parasite destruction maintained for fish products for 90 days
	5.	TIME/TEMPERATURE CONTROLS
	5.1	Inadequate Cook*
IN&OUT NA&NO	A.	Raw eggs broken on request and prepared for immediate service cooked to 63° C (145° F) for 15 seconds. Raw eggs broken, but not prepared for immediate service cooked to 68° C (155° F) for 15 seconds
IN&OUT&NA&NO	B.	Comminuted fish, meat, and game animals cooked to 68° C (155° F) for 15 seconds
IN&OUT&NA&NO	C.	Pork roasts and beef roasts, including formed roasts, cooked to 54° C (130° F) for 121 minutes or as chart specified and according to oven parameters per chart
IN&OUT&NA&NO	D.	Ratites and injected meats cooked to 68° C (155° F) for 15 seconds
IN&OUT&NA&NO	E.	Poultry; stuffed fish/meat/pasta/poultry/ratites; or stuffing containing fish, meat, poultry, or ratites cooked to 74° C (165° F) for 15 seconds
IN&OUT&NA&NO	F.	Wild game animals cooked to 74° C (165° F) for 15 seconds
IN&OUT&NA&NO	G.	Whole-muscle, intact beef steaks cooked to surface temperature of 63° C (145° F) on top and bottom. Meat surfaces has a cooked color
IN&OUT&NA&NO	H.	Raw animal foods rotated, stirred, covered, and heated to 74° C (165° F) in microwave. Food stands for 2 minutes after cooking
IN&OUT&NA&NO	I.	All other raw animal foods cooked to 63° C (145° F) for 15 seconds
	5.2	*Reheating for Hot Holding*
IN&OUT&NA&NO	A.	PHF that is cooked and cooled on premises is rapidly reheated to 74° C (165° F) for 15 seconds*
IN&OUT&NA&NO	B.	Food reheated to 74° C (165° F) or higher in a microwave*
IN&OUT&NA&NO	C.	Commercially processed RTE, food reheated to 60° C (140° F) or above*
IN&OUT&NA&NO	D.	Remaining unsliced portions of beef roasts reheated for hot holding using minimum oven parameters*
	5.3	*Treating Juice*
IN&OUT&NA&NO		When packaged in a a food establishment, juice is treated under a HACCP Plan to reduce pathogens or labeled as specified in the Food Code.
	5.4	*Cooling**
IN&OUT&NA&NO	A.	Cooked PHF cooled from 60° C (140° F) to 21° C (70° F) within 2 hours and from 60° C (140° F) to 7° C / 5° C (45° F / 41° F) or below within 6 hours
IN&OUT&NA&NO	B.	PHF (from ambient temperature ingredients) cooled to 7° C / 5° C (45° F / 41° F) or below within 4 hours
IN&OUT&NA&NO	C.	Foods (milk/shellfish) received at a temperature according to LAW cooled to 7° C / 5° C (45° F / 41° F) within 4 hours
	D.	After receiving, raw shell eggs placed in 7ºC (45ºF) ambient air temperature
	5.5	*PHF Cold & Hot Holding**
IN&OUT	A.	PHF maintained at 7° C / 5° C (45° F / 41° F) or below, except during preparation, cooking, cooling or when time is used as a public health control
IN&OUT&NA&NO	B.	PHF maintained at 60° C (140° F) or above, except during preparation, cooking, or cooling or when time is used as a public health control
IN&OUT&NA&NO	C.	Roasts held at a temperature of 54° C (130° F) or above
IN&OUT&NA&NO	D.	Untreated shell eggs stored in 7ºC (45ºF) ambient air temperature
	5.6	Date Marking & Discarding*
IN&OUT&NA&NO	A.	Date marking for RTE, PHF prepared on-site and opened commercial container held for more than 24 hours
IN&OUT&NA&NO	B.	Discarding RTE, PHF prepared on site or opened commercial container held at < 5 ° C (41° F) for <7 days or > 5° C - 7° C (41° F - 45° F) for <4 days
	5.7	Time*
IN&OUT&NA&NO		When only time is used as a public health control, food is cooked and served within 4 hours
	6.	FOOD & FOOD PREPARATION FOR HIGHLY SUSCEPTIBLE POPULATIONS*
IN&OUT&NA	A.	Prepackaged juice/beverage containing juice with a warning label (21 CFR, Section 101.17(g)) not served
IN&OUT&NA&NO	B.	Use pasteurized eggs in recipes if eggs are undercooked; and if eggs are combined unless: cooked to order & immediately served; used immediately before baking and thoroughly cooked; or a HACCP plan controls Salmonella Enteritidis
IN&OUT&NA&NO	C.	Raw or partially cooked animal food and raw seed sprouts not served
IN&OUT&NA&NO	D.	Unopened food package not re-served
	7.	PROTECTION FROM CONTAMINATION*
IN&OUT&NA NO	A.	Separating raw animal foods from raw RTE food and separating raw animal foods from cooked RTE food
IN&OUT&NA NO	B.	Raw animal foods separated from each other during storage, preparation, holding, and display
IN&OUT	C.	Food protected from environmental contamination - critical items
IN&OUT	D.	After being served or sold to a consumer, food is not re-served
IN&OUT	E.	Discarding or reconditioning unsafe, adulterated or contaminated food
	8.	FOOD-CONTACT SURFACES
IN&OUT		Food-contact surfaces and utensils are clean to sight and touch and sanitized before use*
	9.	PROPER, ADEQUATE HANDWASHING
IN&OUT NO		Hands clean and properly washed*
	10.	GOOD HYGIENIC PRACTICES*
IN&OUT NO		Food employees eat, drink, and use tobacco only in designated areas / do not use a utensil more than once to taste food that is sold or served / do not handle or care for animals present. Food employees experiencing persistent sneezing, coughing, or runny nose do not work with exposed food, clean equipment, utensils, linens, or unwrapped single-service or single-use articles*
	11.	PREVENTION OF CONTAMINATION FROM HANDS*
IN&OUT NA NO		Exposed, RTE food not touched by bare hands*
	12.	HANDWASH FACILITIES
IN&OUT	A.	Handwash facilities conveniently located and accessible for employees*
IN&OUT	B.	Handwash facilities supplied with hand cleanser / sanitary towels / hand drying devices/signage
	13.	CHEMICAL
IN&OUT&NA	A.	If used, no unapproved food or color additives. Sulfites not applied to fresh fruits and vegetables intended for raw consumption*
IN&OUT	B.	Poisonous or toxic materials, chemicals, lubricants, pesticides, medicines, first aid supplies*, and other personal care items properly identified, stored, and used
IN&OUT&NA	C.	Poisonous or toxic materials held for retail sale properly stored*
	14.	CONFORMANCE WITH APPROVED/REQUIRED PROCEDURES*
IN&OUT&NA	A.	Variance & HACCP plan required for ROP with 1 barrier* and Conformance with Required Procedures
IN&OUT&NA	B.	Conducting reduced oxygen packaging with 2 barriers - HACCP plan required*

FOODBORNE ILLNESS INTERVENTIONS AND RISK FACTORS

*Indicates critical items

STATUS

DEMONSTRATION OF KNOWLEDGE

IN&OUT

Code compliance, certified via testing with accredited program, or responses to safety questions regarding operation*

EMPLOYEE HEALTH

IN&OUT

Management awareness and policy regarding handling employee health situations*

IN&OUT

Visible or known symptoms / or known diagnosis dealt with according to Food Code*

CONSUMER ADVISORY*

IN&OUT&NA

Inform consumers about the increased risk associated with especially vulnerable consumers when eating animal foods in raw or undercooked form via disclosure and reminder.

FOOD FROM APPROVED SOURCE

IN&OUT

All food from regulated food processing plants / no home prepared or canned foods*

IN&OUT&NA

All shellfish from NSSP listed sources / no recreationally caught shellfish received or sold*

IN&OUT&NA NO

Game and wild mushrooms approved by regulatory authority*

IN&OUT

Food received at proper temperatures / protected from contamination during transportation and receiving / safe and unadulterated food*

IN&OUT&NA NO

Shellstock tags retained for 90 days from the date the container is emptied*

IN&OUT&NA NO

Written documentation of parasite destruction maintained for fish products for 90 days

TIME/TEMPERATURE CONTROLS

5.1

Inadequate Cook*

IN&OUT

NA&NO

Raw eggs broken on request and prepared for immediate service cooked to 63° C (145° F) for 15 seconds. Raw eggs broken, but not prepared for immediate service cooked to 68° C (155° F) for 15 seconds

IN&OUT&NA&NO

Comminuted fish, meat, and game animals cooked to 68° C (155° F) for 15 seconds

IN&OUT&NA&NO

Pork roasts and beef roasts, including formed roasts, cooked to 54° C (130° F) for 121 minutes or as chart specified and according to oven parameters per chart

IN&OUT&NA&NO

Ratites and injected meats cooked to 68° C (155° F) for 15 seconds

IN&OUT&NA&NO

Poultry; stuffed fish/meat/pasta/poultry/ratites; or stuffing containing fish, meat, poultry, or ratites cooked to 74° C (165° F) for 15 seconds

IN&OUT&NA&NO

Wild game animals cooked to 74° C (165° F) for 15 seconds

IN&OUT&NA&NO

Whole-muscle, intact beef steaks cooked to surface temperature of 63° C (145° F) on top and bottom. Meat surfaces has a cooked color

IN&OUT&NA&NO

Raw animal foods rotated, stirred, covered, and heated to 74° C (165° F) in microwave. Food stands for 2 minutes after cooking

IN&OUT&NA&NO

All other raw animal foods cooked to 63° C (145° F) for 15 seconds

5.2

Reheating for Hot Holding

IN&OUT&NA&NO

PHF that is cooked and cooled on premises is rapidly reheated to 74° C (165° F) for 15 seconds*

IN&OUT&NA&NO

Food reheated to 74° C (165° F) or higher in a microwave*

IN&OUT&NA&NO

Commercially processed RTE, food reheated to 60° C (140° F) or above*

IN&OUT&NA&NO

Remaining unsliced portions of beef roasts reheated for hot holding using minimum oven parameters*

5.3

Treating Juice

IN&OUT&NA&NO

When packaged in a a food establishment, juice is treated under a HACCP Plan to reduce pathogens or labeled as specified in the Food Code.

5.4

Cooling*

IN&OUT&NA&NO

Cooked PHF cooled from 60° C (140° F) to 21° C (70° F) within 2 hours and from 60° C (140° F) to 7° C / 5° C (45° F / 41° F) or below within 6 hours

IN&OUT&NA&NO

PHF (from ambient temperature ingredients) cooled to 7° C / 5° C (45° F / 41° F) or below within 4 hours

IN&OUT&NA&NO

Foods (milk/shellfish) received at a temperature according to LAW cooled to 7° C / 5° C (45° F / 41° F) within 4 hours

After receiving, raw shell eggs placed in 7ºC (45ºF) ambient air temperature

5.5

PHF Cold & Hot Holding*

IN&OUT

PHF maintained at 7° C / 5° C (45° F / 41° F) or below, except during preparation, cooking, cooling or when time is used as a public health control

IN&OUT&NA&NO

PHF maintained at 60° C (140° F) or above, except during preparation, cooking, or cooling or when time is used as a public health control

IN&OUT&NA&NO

Roasts held at a temperature of 54° C (130° F) or above

IN&OUT&NA&NO

Untreated shell eggs stored in 7ºC (45ºF) ambient air temperature

5.6

Date Marking & Discarding*

IN&OUT&NA&NO

Date marking for RTE, PHF prepared on-site and opened commercial container held for more than 24 hours

IN&OUT&NA&NO

Discarding RTE, PHF prepared on site or opened commercial container held at < 5 ° C (41° F) for <7 days or > 5° C - 7° C (41° F - 45° F) for <4 days

5.7

Time*

IN&OUT&NA&NO

When only time is used as a public health control, food is cooked and served within 4 hours

FOOD & FOOD PREPARATION FOR HIGHLY SUSCEPTIBLE POPULATIONS*

IN&OUT&NA

Prepackaged juice/beverage containing juice with a warning label (21 CFR, Section 101.17(g)) not served

IN&OUT&NA&NO

Use pasteurized eggs in recipes if eggs are undercooked; and if eggs are combined unless: cooked to order & immediately served; used immediately before baking and thoroughly cooked; or a HACCP plan controls Salmonella Enteritidis

IN&OUT&NA&NO

Raw or partially cooked animal food and raw seed sprouts not served

IN&OUT&NA&NO

Unopened food package not re-served

PROTECTION FROM CONTAMINATION*

IN&OUT&NA NO

Separating raw animal foods from raw RTE food and separating raw animal foods from cooked RTE food

IN&OUT&NA NO

Raw animal foods separated from each other during storage, preparation, holding, and display

IN&OUT

Food protected from environmental contamination - critical items

IN&OUT

After being served or sold to a consumer, food is not re-served

IN&OUT

Discarding or reconditioning unsafe, adulterated or contaminated food

FOOD-CONTACT SURFACES

IN&OUT

Food-contact surfaces and utensils are clean to sight and touch and sanitized before use*

PROPER, ADEQUATE HANDWASHING

IN&OUT NO

Hands clean and properly washed*

10.

GOOD HYGIENIC PRACTICES*

IN&OUT NO

Food employees eat, drink, and use tobacco only in designated areas / do not use a utensil more than once to taste food that is sold or served / do not handle or care for animals present. Food employees experiencing persistent sneezing, coughing, or runny nose do not work with exposed food, clean equipment, utensils, linens, or unwrapped single-service or single-use articles*

11.

PREVENTION OF CONTAMINATION FROM HANDS*

IN&OUT NA NO

Exposed, RTE food not touched by bare hands*

12.

HANDWASH FACILITIES

IN&OUT

Handwash facilities conveniently located and accessible for employees*

IN&OUT

Handwash facilities supplied with hand cleanser / sanitary towels / hand drying devices/signage

13.

CHEMICAL

IN&OUT&NA

If used, no unapproved food or color additives. Sulfites not applied to fresh fruits and vegetables intended for raw consumption*

IN&OUT

Poisonous or toxic materials, chemicals, lubricants, pesticides, medicines, first aid supplies*, and other personal care items properly identified, stored, and used

IN&OUT&NA

Poisonous or toxic materials held for retail sale properly stored*

14.

CONFORMANCE WITH APPROVED/REQUIRED PROCEDURES*

IN&OUT&NA

Variance & HACCP plan required for ROP with 1 barrier* and Conformance with Required Procedures

IN&OUT&NA

Conducting reduced oxygen packaging with 2 barriers - HACCP plan required*

SCORE: Number of disagreements for Interventions/Risk Factors:______________

**GOOD RETAIL PRACTICES (GRPs)**
*Indicates items that are always critical according to the FDA Food Code. The item requires immediate attention.
STATUS
		PERSONNEL
IN&OUT&NA	15.	Personal Cleanliness (fingernails, jewelry, outer clothing, hair restraints)
		FOOD & FOOD PROTECTION
IN&OUT	16.	Food source, original container, properly labeled, condition, used, honestly presented*, segregated distressed products
IN&OUT&NA&NO	17.	Plant food cooking for hot holding
IN&OUT	18.	Protection from contamination - noncritical items
IN&OUT	19.	Facilities / equipment to control product temperature
IN&OUT&NA&NO	20.	PHF properly thawed
IN&OUT	21.	Dispensing of food / utensils properly stored
		FOOD EQUIPMENT
IN&OUT	22.	Thermometers provided and conspicuous
IN&OUT	23.	Food- and nonfood-contact surfaces: designed / constructed, maintained, installed, located, operated, cleanable
IN&OUT	24.	Warewashing facility: designed, constructed, installed, located, operated, cleanable, used
IN&OUT	25.	Wiping cloths, linens, napkins, gloves, sponges: properly used, stored
IN&OUT	26.	Storage, handling of clean equipment, utensils
IN&OUT	27.	Single-service / single-use articles: storage, dispensing, use, no reuse
		WATER
IN&OUT	28.	Safe water source, hot & cold under pressure, adequate quantity
		PLUMBING
IN&OUT	29.	Installed, maintained*
IN&OUT	30.	Cross connection, back siphonage, backflow prevention
		TOILET FACILITIES
IN&OUT	31.	Number, convenient, accessible, designed, installed
IN&OUT	32.	Toilet rooms enclosed, self-closing doors; proper waste receptacles
		SEWAGE
IN&OUT	33.	Sewage and waste water disposal*
		GARBAGE & REFUSE DISPOSAL
IN&OUT	34.	Containers or receptacles: covered, adequate number, insect / rodent proof, frequency of removal, clean. Area properly constructed, necessary implements, supplies
		PHYSICAL FACILITY
IN&OUT	35.	Floors, walls, ceilings: designed, constructed, maintained, clean
IN&OUT	36.	Lighting, ventilation, dressing rooms / designated areas maintained
IN&OUT	37.	Premises maintained free of litter, unnecessary articles, cleaning and maintenance equipment properly stored
IN&OUT	38.	Complete separation from living / sleeping quarters; laundry
		PEST & ANIMAL CONTROL
IN&OUT	39.	Presence of insects / rodents minimized: outer openings protected, animals as allowed
		SPECIALIZED PROCESSING METHODS
IN&OUT&NA	40.	DOCUMENTATION OF VARIANCE FOR SMOKING FOR PRESERVATION, CURING, USING ADDITIVES AS PRESERVATIVES, OR USING REDUCED OXYGEN (1 barrier only) TO PACKAGE FOOD

GOOD RETAIL PRACTICES (GRPs)

*Indicates items that are always critical according to the FDA Food Code. The item requires immediate attention.

STATUS

PERSONNEL

IN&OUT&NA

15.

Personal Cleanliness (fingernails, jewelry, outer clothing, hair restraints)

FOOD & FOOD PROTECTION

IN&OUT

16.

Food source*, original container, properly labeled, condition, used*, honestly presented*, segregated distressed products

IN&OUT&NA&NO

17.

Plant food cooking for hot holding

IN&OUT

18.

Protection from contamination - noncritical items

IN&OUT

19.

Facilities / equipment to control product temperature

IN&OUT&NA&NO

20.

PHF properly thawed

IN&OUT

21.

Dispensing of food / utensils properly stored

FOOD EQUIPMENT

IN&OUT

22.

Thermometers provided and conspicuous

IN&OUT

23.

Food- and nonfood-contact surfaces: designed / constructed*, maintained, installed, located, operated, cleanable*

IN&OUT

24.

Warewashing facility: designed, constructed, installed, located, operated, cleanable, used

IN&OUT

25.

Wiping cloths, linens, napkins, gloves, sponges: properly used, stored

IN&OUT

26.

Storage, handling of clean equipment, utensils

IN&OUT

27.

Single-service / single-use articles: storage, dispensing, use, no reuse

WATER

IN&OUT

28.

Safe water source*, hot & cold under pressure, adequate quantity*

PLUMBING

IN&OUT

29.

Installed, maintained*

IN&OUT

30.

Cross connection*, back siphonage, backflow prevention*

TOILET FACILITIES

IN&OUT

31.

Number, convenient, accessible, designed, installed

IN&OUT

32.

Toilet rooms enclosed, self-closing doors; proper waste receptacles

SEWAGE

IN&OUT

33.

Sewage and waste water disposal*

GARBAGE & REFUSE DISPOSAL

IN&OUT

34.

Containers or receptacles: covered, adequate number, insect / rodent proof, frequency of removal, clean. Area properly constructed, necessary implements, supplies

PHYSICAL FACILITY

IN&OUT

35.

Floors, walls, ceilings: designed, constructed, maintained, clean

IN&OUT

36.

Lighting, ventilation, dressing rooms / designated areas maintained

IN&OUT

37.

Premises maintained free of litter, unnecessary articles, cleaning and maintenance equipment properly stored

IN&OUT

38.

Complete separation from living / sleeping quarters; laundry

PEST & ANIMAL CONTROL

IN&OUT

39.

Presence of insects / rodents minimized: outer openings protected, animals as allowed

SPECIALIZED PROCESSING METHODS

IN&OUT&NA

40.

DOCUMENTATION OF VARIANCE FOR SMOKING FOR PRESERVATION, CURING, USING ADDITIVES AS PRESERVATIVES, OR USING REDUCED OXYGEN (1 barrier only) TO PACKAGE FOOD

SCORE: Number of disagreements for Good Retail Practices:______________

ABREVIATIONS
"CCP"	Critical Control Point
"CL"	Critical Limit
"GRP"	Good Retail Practice
"HACCP"	Hazard Analysis Critical Control Point
"HSP"	Highly Susceptible Population
"NSSP"	National Shellfish Sanitation Program
"PHF"	Potentially Hazardous Food
"RTE"	Ready-to-Eat
"RCP"	Risk Control Plan

U. S. Department of Health and Human Services Public Health Service Food and Drug Administration

FDA Procedures for Standardization and Certification of Retail Food Inspection/Training Officers

FDA Standardization Inspection Report

FDA Standardization Inspection Report

U. S. Department of Health and Human Services
Public Health Service
Food and Drug Administration

FDA Procedures for Standardization and Certification
of Retail Food Inspection/Training Officers