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DEPARTMENT OF HEALTH AND HUMAN

FOOD AND DRUG ADMINISTRATION

FOOD GMP INSPECTION REPORT
1. ESTABLISHMENT NAME AND ADDRESS (Include ZIP code)
2. DATE INSPECTED

3. PRODUCT(S) INSPECTED

4. STATE LICENSE OR PERMIT NUMBER

5. NAME AND TITLE OF RESPONSIBLE PLANT OFFICIAL

6. TELEPHONE NUMBER (Include Area Code)

7. NAME AND TITLE OF RESPONSIBLE CORPORATE OFFICIAL

8. TELEPHONE NUMBER (Include Area Code)

INSTRUCTIONS: Answer the following questions by checking the appropriate box. Explain "No", answers on continuation sheet(s). Precede each explanation with the item number. Use "N/A" where questions are Not Applicable.

INSPECTION CRITERIA NO. 1. 2. 3. 4. 5. 6. PLANTS AND GROUNDS
Are premises free of harborages and/or breeding places for rodents, insects and other pests Is adequate drainage provided to avoid contamination of facilities and products Is sufficient space provided for placement of equipment, storage of materials and for production operations Are floors, walls and ceilings constructed of easily cleanable materials and kept clean and in good repair Are food and food contact surfaces protected from contamination from pipes, etc., over working areas Are food processing areas effectivly separated from other operations which may cause contamination of food being processed Are food products and processing areas protected against contamination from breakage of light bulbs and other glass fixtures Is air quality and ventilation adequate to prevent contamination by dust and/or other airborne substances Are doors, windows and other oponings protected to eliminate entry by insects, rodents and other pests

YES

NO

7. 8. 9.

EQUIPMENT AND UTENSILS

10. 11. 12.

Are all utensils and equipment constructed of adequately cleanable materials and suitable for their intended uses Is the equipment designed and used in a manner that precludes contamination with lubricants, contaminated water, metal fragments, etc. Is the equipment installed and maintained so as to facilitate the cleaning of equipment and adjacent areas PAGE 1 OF 4
Created by: PSC Media Arts (301) 443-2454 XFT

FORM FDA 2966 (10/88)

INSPECTION CRITERIA NO. 13. 14. 15. 16. 17. 18. 19. SANITARY FACILITIES AND CONTROLS
Is the water supply adequate in quantity and quality for its intended uses Are the water temperatures and pressures maintained at suitable levels for its intended use Is the sewage disposal system adequate
Is the plumbing adequately sized, designed, installed and maintained in a manner to prevent contaminatio

YES

NO

Are adequate toilet rooms provided, equipped and maintained clean and in good repair Are adequate handwashing and/or sanitizing facilities provided where appropriate Is all refuse properly stored and protected where necessary from insects, rodents and other pests and disposed of in an adequate manner

SANITARY OPERATIONS 20. 21 22. 23. 24. 25. 26. 27. 28.
Is the facility kept clean and in good physical repair Is cleaning of facilities and equipment conducted in such a manner as to avoid contamination of food products Are detergents, sanitizors, hazardous materials and other supplies used in a safe and effective manner Are cleaning compounds and hazardous materials kept in original containers, stored separate from raw materials Are the processing areas maintained free of insects, rodents and other pests Are insecticides and rodenticides used and stored so as to prevent contamination of food Are all utensils and equipment cleaned and sanitized at intervals frequent enough to avoid contamination of food products Are single service articles stored, handled, dispensed, used and disposed of in a manner that prevents contamination Are utensils and portable equipment stored so as to protect them from splash, dust and other contamination

PROCESSES AND CONTROLS 29. 30. 31. 32. 33. 34. 35. 36. 37.
Is responsibility for overall plant sanitation specifically assigned to an individual Are raw materials and ingredients adequately inspected, processed as necessary and stored to assure that only clean, wholesome materials are used Is ice (where used) manufactured from potable water and stored and handled in a sanitary manner
Is food processing conducted in a manner to prevent contamination and minimize harmful microbicilogical growth

Are chemical microbiological or extraneous material testing procedures used where necessary to identify sanitation failures of food contamination Are packaging processes and materials adequate to prevent contamination Are only approved food and/or color additives used Are products coded to enable positive lot identification, and are records maintained in excess of expected shelf-life Are weighing and measuring practices adequate to ensure the declared quantity of contents
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FORM FDA 2966 (10/88)

INSPECTION CRITERIA NO. 38. 39. PROCESSES AND CONTROLS
Are labels of products covered during inspection in compliance (submit violative labels as exhibits) Are finished products stored and shipped under conditions which will avoid contamination and deterioration

YES

NO

DETAILS OF MANUFACTURING PROCEDURES AND CONTROLS
Provide brief description of manufacturing processes and controls for product(s) inspected. Where appropriate, report times, temperatures, and other critical processing steps. If microbiological or any other type of contamination is suspected or encountered, fully describe the relationship between the routes of contamination and the process. Use flow charts where appropriate. If more space is needed, use continuation sheet.

NO. 40. 41. 42. 43.

PERSONNEL
Are personnel with sores, infections, etc., restricted from handling food products Do employees wear clean outer garments, use adequate hair restraints and remove excess jewelry when handling food Do employees thoroughly wash and sanitize hands as necessary Do employees refrain from eating, drinking and smoking and observe good food handhng techniques in processing areas

YES

NO

FORM FDA 2966 (10/88)

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CORRECTIONS AND SAMPLES
If any corrections were made as a result of this inspection or made as a result of a previous inspection (including voluntary destructions, capital improvements, etc.), complete Voluntary Correction section of cover sheet Form FDA 481 (E) CG. If any samples were collected, list sample numbers and briefly describe samples.

DISCUSSIONS WITH MANAGEMENT
Indicate individual with whom inspection was discussed. Identify official (name and title) having authority to authorize corrections. Record any recommendations/warnings given, and management's response.

CONTINUATION SHEET
(Use additional sheets as appropriate.)

SIGNATURE OF INSPECTOR

DATE

FORM FDA 2966 (10/88)

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