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U.S. Department of Health and Human Services


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FDA Standardization Inspection Report - Annex 2, Section 1

FDA Procedures for Standardization of Retail Food Safety Inspection Officers

Table of Contents


FDA Standardization Inspection Report
Establishment Name:
Type of Facility:
Physical Address:
Person in Charge:
Inspection Time In:
Inspection Time Out:
Candidate’s Name:
Standard’s Name:
Person Completing Form:
(circle one)
Candidate OR Standard
Foodborne Illness Risk Factors
Food Code Interventions
Food from Unsafe Sources
Demonstration of Knowledge
Improper Holding Temperatures
Hands as a Vehicle of Contamination
Poor Personal Hygiene
Employee Health
Inadequate Cooking Temperatures
Time/Temperature Relationships
Contaminated Equipment/ Cross-Contamination
Consumer Advisory


For each item, indicate one of the following for OBSERVATIONAL STATUS:
IN – Item found in compliance                                   NO – Not observed
OUT – Item found out of compliance                          NA – 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.
“CCP” means Critical Control Point
“CL” means Critical Limit
“GRP” means Good Retail Practice
“HACCP” means Hazard Analysis and Critical Control Point
“HSP” means Highly Susceptible Population
“ICSSL” means Interstate Certified Shellfish Shippers List
“PHF/TCS Food” means Potentially Hazardous Food/ Time/Temperature Control for Safety Food
“RTE” means Ready-to-Eat


    1. Person in charge present, demonstrates knowledge, and performs duties
IN OUT          A. Assignment – PIC is present
IN OUT          B. Demonstration – Code compliance, certified via testing with accredited
                        program, or responses to safety questions regarding operation
IN OUT          C. Duties of PIC
Employee Health
IN OUT          2. Management, food employee and conditional employee; Knowledge,
                              responsibilities and reporting
IN OUT          3. Proper use of restriction and exclusion
Good Hygienic Practices
IN OUT           4. Proper eating, tasting, drinking, or tobacco use
IN OUT           5. No discharge from eyes, nose, and mouth
Control of Hands as a Vehicle of Contamination
IN OUT           6. Hands clean & properly washed
IN OUT           7. No bare hand contact with RTE foods or a pre-approved
NA NO                alternative procedure properly followed
      8. Handwashing sinks properly supplied and accessible
IN OUT           A. Handwashing sinks conveniently located and accessible for employees
IN OUT           B. Handwashing sinks supplied with hand cleanser/sanitary towels/hand                                
                             drying devices/ signage

Approved Source
               9. Food obtained from approved source
IN OUT          A. All food from regulated food processing plants/no home prepared or
                        canned foods/standards for eggs, milk, juice
IN OUT          B. All Molluscan shellfish for ICSSL listed sources/no recreationally
NA NO               caught shellfish received or sold/all fish commercially caught/raised
IN OUT          C. Game animals and wild mushrooms approved by regulatory authority
IN OUT          10. Food received at proper temperature
IN OUT          11. Food in good condition, safe, and unadulterated
                    12. Required records available: shellstock tags, parasite destruction
IN OUT          A. Written documentation of parasite destruction maintained for 90 days
NA NO               for fish products that are intended for raw or undercooked consumption         
IN OUT          B. Shellstock tags maintained for 90 days in chronological order
Protection from Contamination
     13. Food separated and protected
IN OUT          A. Separating raw animal foods from raw RTE food and separating raw
NA NO               animal food from cooked RTE food
IN OUT             B. Raw animal foods separated from each other during storage,
NA NO               preparation, holding, and display
IN OUT          C. Food protected from environmental contamination
IN OUT          14. Food-contact surfaces: cleaned and sanitized 
     15. Proper disposition of returned, previously served, reconditioned,
                                and unsafe food 
IN OUT           A. After being served or sold to a consumer, food is not reserved                          
IN OUT           B. Discarding or reconditioning unsafe, adulterated, or contaminated


Potentially Hazardous Food(PHF) Time/Temperature Control for Safety(TCS)
   16. Proper cooking time & temperatures
IN OUT          A. Raw eggs broken on request and prepared for immediate service
NA NO               cooked to 63°C (145°F) for 15 seconds
IN OUT          B. Comminuted fish, meat, game animals commercially raised for food
NA NO                   and raw eggs not prepared for immediate service and comminuted
                        meat on a child’s menu cooked to 68°C (155°F) for 15 seconds or the
                        time/temperature relationship specified in the chart in the Food Code.
IN OUT           C. Whole meat roast, including beef, corned beef, lamb, pork, cured pork
NA NO                roasts and formed roasts, cooked to 54°C (130°F) for 112 minutes or
                         as chart specifies and according to oven parameters per chart
IN OUT           D. Ratites and injected meats or mechanically tenderized meats cooked to
NA NO                    68°C (155°F) for 15 seconds or the time/temperature relationship
                         specified in the chart in the Food Code.
IN OUT           E. Poultry; baluts; stuffed fish/meat/poultry/ratites/pasta or stuffing
NA NO               containing fish, meat, poultry, or ratites; or raw animal foods with a non-                        
                        continuous cooking process cooked to 74°C (165°F) for 15 seconds
IN OUT           F. Wild game animals cooked to 74°C (165°F) for 15 seconds
IN OUT           G. Whole-muscle, intact beef steaks cooked to surface temperature of
NA NO                63°C (145°F) on top and bottom. Meat surface has a cooked color.
IN OUT           H. Raw animal foods rotated, stirred, covered, and heated to 74°C
NA NO               (165°F) in microwave. Food stands for 2 minutes after cooking.
IN OUT           I.  All other raw animal foods cooked to 63°C (145°F) for 15 seconds
    17. Proper reheating procedures for hot holding
IN OUT           A. PHF/TCS Food that is cooked and cooled on premises is rapidly
NA NO               reheated within 2 hours to 74°C (165°F) or above for 15 seconds for
                        hot holding
IN OUT           B.  Food reheated to 74°C (165°F) or above in microwave for hot holding
IN OUT           C.  Commercially processed, RTE food reheated to 57°C (135°F) or above
NA NO                for hot holding
IN OUT           D. Remaining unsliced portions of roasts reheated for hot holding using
NA NO               minimum oven parameters
    18. Proper cooling time & temperatures
IN OUT           A. Cooked PHF/TCS Food cooled from 57°C (135°F) to 21°C (70°F)
NA NO               within 2 hours and from 57°C (135°F) to 5°C (41°F) or below in 6
IN OUT           B. PHF/TCS Food prepared from ambient temperature and/or pre-chilled
NA NO               ingredients) cooled to 5°C (41°F) or below in 4 hours
IN OUT           C. Foods (milk/shellfish) received at a temperature according to law
NA NO               cooled to 5°C (41°F) or below in 4 hours
IN OUT           D. Immediately upon receiving, eggs placed under refrigeration that
NA NO               maintains ambient air temperature of 7°C (45°F)
    19. Proper hot holding temperatures
IN OUT           A. PHF/TCS Food maintained at 57°C (135°F) or above, except during
NA NO               preparation, cooking, or cooling, or when time is used as a public
                        health control
IN OUT           B. Roasts held at a temperature of 54°C (130°F) or above
   20. Proper cold holding temperatures
IN OUT           A. PHF/TCS Food maintained at 5°C (41°F) or below, except during
NA                    preparation, cooking, cooling, or when time is used as a public health
IN OUT           B. Untreated eggs stored in 7°C (45°F) ambient air temperature
    21. Proper date marking & disposition
IN OUT           A. Date marking for RTE, PHF/TCS Food prepared on-site or opened
NA NO               commercial container held for more than 24 hours
IN OUT           B. Discarding RTE, PHF/TCS Food prepared on-site or opened
NA NO               commercial container held at ≤5°C (41°F) for ≤ 7 days
IN OUT          22. Time as a public health control: procedures & records
Consumer Advisory
IN OUT          23. Consumer advisory provided for raw or undercooked foods
Highly Susceptible Populations
     24. Pasteurized foods used; prohibited foods not offered
IN OUT           A. Prepackaged juice/beverage containing juice with a warning label [21
NA                    CFR, Section 101.17(g)] not served
IN OUT           B. Using pasteurized eggs in recipes if eggs are to be undercooked; or are
NA                     combined unless: cooked to order & immediately served; used
                         immediately before baking and thoroughly cooked; or prepared under
                         a HACCP plan controlling Salmonella Enteritidis
IN OUT           C. Raw or partially cooked animal food and raw seed sprouts not served
IN OUT           D. Foods not re-served under certain conditions
Food/Color Additives and Toxic Substances
IN OUT          25. Food additives: approved and properly used
     26. Toxic substances properly identified, stored, and used
IN OUT           A. Poisonous or toxic materials, chemicals, lubricants, pesticides,
                        medicines, first aid supplies, and other personal care items properly
                        identified, stored, and used
IN OUT           B. Poisonous or toxic materials held for retail sale properly stored
Conformance with Approved Procedures
    27. Compliance with variance, specialized process, ROP Criteria &
                               HACCP plan
IN OUT           A. Reduced Oxygen Packaging (ROP) as specified in 3-502.12 permitted
NA                    without a variance under certain specified conditions in accordance
                        with a required HACCP plan.
IN OUT           B. Operating in accordance with approved variance and/or HACCP plan
NA                    when required
IN OUT           C. When packaged in a food establishment, juice is treated under a
NA                    HACCP plan to reduce pathogens or labeled as specified in the Food


Safe Food and Water
IN OUT          28. Pasteurized eggs used where required
IN OUT          29. Water and ice from approved source
IN OUT          30. Variance obtained for specialized processing methods
Food Temperature Control
IN OUT          31. Proper cooling methods used; adequate equipment for
                                temperature control 
IN OUT          32. Plant food properly cooked for hot holding
IN OUT          33. Approved thawing methods used
IN OUT          34. Thermometers provided & accurate
Food Identification
IN OUT          35. Food properly labeled; original container       
Prevention of Food Contamination
IN OUT          36. Insects, rodents, & animals not present/outer openings protected
IN OUT          37. Contamination prevented during food preparation, storage &
IN OUT          38. Personal cleanliness
IN OUT          39. Wiping cloths: properly used & stored
IN OUT          40. Washing fruits & vegetables
Proper Use of Utensils
IN OUT          41. In-use utensils: properly stored
IN OUT          42. Utensils, equipment & linens: properly stored, dried, & handled
IN OUT          43. Single-use/single-service articles: properly stored & used
IN OUT          44. Gloves used properly
Utensils, Equipment and Vending
IN OUT          45. Food & non-food contact surfaces cleanable, properly designed,
                                constructed, & used
IN OUT          46. Warewashing facilities: installed, maintained, & used; test strips
IN OUT          47. Non-food contact surfaces clean
Physical Facilities
IN OUT          48. Hot & cold water available; adequate pressure
IN OUT          49. Plumbing installed; proper backflow devices 
IN OUT          50. Sewage & waste water properly disposed
IN OUT          51. Toilet facilities: properly constructed, supplied, & cleaned
IN OUT          52. Garbage & refuse properly disposed; facilities maintained   
IN OUT          53. Physical facilities installed, maintained, & clean
IN OUT          54. Adequate ventilation & lighting; designated areas used