Free FORM FDA 2359 - Federal

Department of Health and Human Services Public Health Service Food and Drug Administration
NAME AND LOCATION OF PLANT

MILK PLANT INSPECTION REPORT
(Includes Dry MIlk/Condensing Plants, Receiving Stations, Transfer Stations, and MIlk Tank Truck Cleaning Facilities)

INSPECTING AGENCY

POUNDS SOLD DAILY

Milk Other Milk Products Total Permit No.

Inspection of your plant today showed violations existing in the Items checked below. You are further notified that this inspection report serves as notification of the intent to suspend your permit if the violations noted are not in compliance at the time of the next inspection. (Refer to Sections 3 and 5 of the Grade "A" Pasteurized Milk Ordinance.)
1. FLOORS: Smooth; impervious; no pools; good repair; trapped drains ...... (a) 2. WALLS AND CEILINGS: Smooth; washable; light-colored; good repair ....................... (a) 3. DOORS AND WINDOWS: All outer openings effectively protected against entry of flies and rodents ....................................................................... (a) Outer doors self-closing; screen doors open outward ........... (b) 4. LIGHTING AND VENTILATION: Adequate light in all rooms .................................................... (a) Well ventilated to preclude odors and condensation; filtered air with pressure systems ...................................................... (b) 5. SEPARATE ROOMS: Separate rooms as required; adequate size ............................ (a) No direct opening to barn or living quarters ........................... (b) Storage tanks properly vented ................................................ (c) 6. TOILET FACILITIES: Complies with local Ordinances ............................................. (a) No direct opening to processing rooms; self-closing doors ................................................................................. (b) Clean; well-lighted and ventilated; proper facilities................. (c) Sewage and other liquid wastes disposed of in sanitary manner .............................................................................. (d) 7. WATER SUPPLY: Constructed and operated in accordance with Ordinance ...... (a) No direct or indirect connection between safe and unsafe water ................................................................................. (b) Condensing water and vacuum water in compliance with Ordinance requirements .................................................... (c) Reclaim water complies with Ordinance ................................ (d) Complies with bacteriological standards ................................ (e) 8. HANDWASHING FACILITIES: Located and equipped as required; clean and in good repair; improper facilities not used ............................................... (a) 9. MILK PLANT CLEANLINESS: Neat; clean; no evidence of insects or rodents; trash properly handled .............................................................................. (a) No unnecessary equipment ................................................... (b) No excessive product dust .................................................... (c) 10. SANITARY PIPING: Smooth; impervious, corrosion-resistant, non-toxic, easily cleanable materials; good repair; accessible for inspection ....... (a) CIP cleaned lines meet Ordinance specifications ................... (b) Pasteurized products conducted in sanitary piping, except as permitted by Ordinance ..................................................... (c) 11. CONSTRUCTION AND REPAIR OF CONTAINERS AND EQUIPMENT: Smooth, impervious, corrosion-resistant, non-toxic, easily cleanable materials; good repair; accessible for inspection .......................................................................... (a) Self-draining; strainers and sifters of approved design .......... (b) Approved single-service articles; not reused ......................... (c) 12. CLEANING AND SANITIZING OF CONTAINERS AND EQUIPMENT: Containers, utensils, and equipment effectively cleaned ........ (a) CIP cleaning requirements of Ordinance in compliance; records complete; milk tank trucks cleaned at permitted location .............................................................................. (b) Approved sanitization process applied prior to use of product-contact surfaces .................................................. (c) Required efficiency tests in compliance ................................. (d) Multi-use plastic containers in compliance ............................ (e) Aseptic system sterilized ........................................................ (f) 13. STORAGE OF CLEANED CONTAINERS AND EQUIPMENT: Stored to assure drainage and protected from contamination ... (a) 14. STORAGE OF SINGLE-SERVICE ARTICLES: Received, stored and handled in a sanitary manner; paperboard containers not reused, except as permitted by the Ordinance .................................................................... (a) 15a. PROTECTION FROM CONTAMINATION: Operations conducted and located so as to preclude contamination of milk, milk products, ingredients, containers, equipment, and utensils .................................. (a) Air and steam used to process products in compliance with Ordinance .......................................................................... (b) Approved pesticides, safely used ........................................... (c) 15b. CROSS CONNECTIONS: No direct connections between pasteurized and raw milk or milk products .................................................................... (a) Overflow, spilled and leaked products or ingredients discarded ........................................................................... (b) No direct connections between milk or milk products and cleaning and/or sanitizing solutions .................................. (c) 16a. PASTEURIZATION-BATCH: (1) INDICATING AND RECORDING THERMOMETERS: Comply with Ordinance specifications ................................... (a) (2) TIME AND TEMPERATURE CONTROLS: Adequate agitation throughout holding; agitator sufficiently submerged ........................................................................ (a) Each pasteurizer equipped with indicating and recording thermometer; bulb submerged .......................................... (b) Recording thermometer reads no higher than indicating thermometer ..................................................................... (c) Product held minimum pasteurization temperature continuously for 30 minutes, plus filling time if product preheated before entering vat, plus emptying time, if cooling is begun after opening outlet ................................ (d) No product added after holding begun .................................. (e) Airspace above product maintained at not less than 5°F (3°C) higher than minimum required pasteurization temperature during holding ................................................................... (f) Approved airspace thermometer; bulb not less than 1 inch (25 mm) above product level ............................................ (g) Inlet and outlet valves and connections in compliance with Ordinance .......................................................................... (h) 16b. PASTEURIZATION-HIGH TEMPERATURE: (1) INDICATING AND RECORDING THERMOMETERS: Comply with Ordinance specifications ................................... (a) (2) TIME AND TEMPERATURE CONTROLS: Flow-diversion device complies with Ordinance requirements ..................................................................... (a) Recorder controller complies with Ordinance requirements ..................................................................... (b) Holding tube complies with Ordinance requirements ............. (c) Flow promoting devices comply with Ordinance requirements ..................................................................... (d) Product held minimum pasteurization time and temperature ....................................................................... (e) (3) ADULTERATION CONTROLS: Satisfactory means to prevent adulteration with added water.................................................................................. (a) 16c. ASEPTIC PROCESSING SYSTEMS: (1) INDICATING AND RECORDING THERMOMETERS: Comply with Ordinance specifications ................................... (a) (2) TIME AND TEMPERATURE CONTROLS: Flow-diversion device complies with Ordinance requirements .... (a) Recorder controller complies with Ordinance requirements .................................................................... (b) Holding tube complies with Ordinance requirements ........... (c) Flow promoting devices comply with Ordinance requirements .................................................................... (d) (3) ADULTERATION CONTROLS: Satisfactory means to prevent adulteration with added water ................................................................................ (a) 16d. REGENERATIVE HEATING: Pasteurized or aseptic product in regenerator automatically under greater pressure than raw product in regenerator at all times ................................................................................ (a) Accurate pressure gauges installed as required; booster pump properly identified, when required, and installed .............. (b) Regenerator pressures meet Ordinance requirements .......... (c) 16e. RECORDING CHARTS: Batch pasteurizer charts comply with applicable Ordinance requirements .................................................................... (a) HTST and HHST pasteurizer charts comply with applicable Ordinance requirements ................................................... (b) Aseptic charts comply with applicable Ordinance requirements .................................................................... (c) 17. COOLING OF MILK AND MILK PRODUCTS: Raw milk maintained at 45°F (7°C) or less until processed or as provided for in the Ordinance ........................................... (a) Pasteurized milk and milk products, except those to be cultured, or as provided for in the Ordinance, cooled immediately to 45°F (7°C) or less in approved equipment; all milk and milk products stored thereat until delivered ... (b) Approved thermometer properly located in all refrigeration rooms and storage tanks as required ............................... (c) Recirculated cooling water from a safe source and properly protected; complies with bacteriological standards .......... (d) 18. BOTTLING, PACKAGING AND CONTAINER FILLING: Performed in a plant where contents finally pasteurized, except for dry milk and whey products ............................ (a) Performed in a sanitary manner by approved mechanical equipment ........................................................................ (b) Aseptic filling in compliance ................................................. (c) Dry milk and whey products packaged in new containers; stored and transported in a sanitary manner .................... (d) 19. CAPPING, CONTAINER CLOSURE AND SEALING: Capping and/or closing/sealing performed in a sanitary manner by approved mechanical equipment .................... (a) Imperfectly capped/closed products properly handled ......... (b) Caps and/or closures comply with Ordinance ....................... (c) 20. PERSONNEL CLEANLINESS: Hands thoroughly washed before performing plant functions; rewashed when contaminated .......................................... (a) Clean outer garments and hair covering worn ...................... (b) No use of tobacco in processing areas ................................. (c) Clean boot covers, caps and coveralls worn when entering dryer ................................................................................. (d) 21. VEHICLES: Vehicles clean; constructed to protect milk .......................... (a) No contaminating substances transported ........................... (b) 22. SURROUNDINGS: Neat and clean; free of pooled water, harborages, and breeding areas .................................................................. (a) Tank unloading areas properly constructed .......................... (b) Approved pesticides, used properly ...................................... (c)

REMARKS

DATE

SANITARIAN

1. A receiving station shall comply with Items 1 to 15, inclusive, and 17, 20, and 22. Separation requirements of Item 5 do not apply. 2. A transfer station shall comply with Items 1, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 22 and as climatic and operating conditions require, applicable provisions of Items 2 and 3. In every case, overhead protection shall be required. 3. Facilities for the cleaning and sanitizing of milk tank trucks shall comply with the same requirements for transfer stations. NOTE: Item numbers correspond to required sanitation Items for Grade "A" pasteurized milk in the Grade "A" Pasteurized Milk Ordinance.

FORM FDA 2359 (10/08)

PSC Graphics (301) 443-1090

EF