Free FDA-2359c - Federal

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION NAME AND LOCATION OF PLANT

(Single-Service Milk Containers and Closures)

MANUFACTURING PLANT INSPECTION REPORT

INSPECTING AGENCY/FIRM

1. FLOORS
Smooth; impervious; in good repair ......................................... (a) Joints between walls and floors tight; impervious .................... (b) Floor drains properly trapped; sloped to drain .......................... (c)

10. LOCKERS AND LUNCHROOMS
Separate from plant operation; self-closing doors .................... (a) Eating/storage of food prohibited in fabrication and storage areas ....................................................................... (b) Locker and lunchrooms clean ................................................... (c) Cleanable trash containers provided; properly labeled; covered ................................................................................ (d) Handwashing facilities convenient ............................................ (e) Employee handwashing signs posted ........................................ (f)

Makeshift devices not used; fasteners, guides, hangers, supports and baffles properly constructed; good repair ........................................................................... (b) Take-off tables and other container contact surfaces properly constructed; clean; in good repair .......................... (c) Grinders, shredders and similar equipment properly installed; protected from contamination ............................... (d) Resin storage silos, other containers, constructed to protect resin from contamination; air vents filtered; air tubes good repair and properly protected ........................ (e)

2. WALLS AND CEILINGS
In fabrication areas--smooth; cleanable; light-colored ............ (a) In fabrication and storage areas--good repair ...................... (b) Openings in walls and ceilings effectively sealed ...................... (c)

3. DOORS AND WINDOWS
All outside openings protected against entrance of insects, rodents, dust, and airborne contamination ...................... (a) Outer doors tight, self-closing .................................................. (b)

11. DISPOSAL OF WASTES
Stored in covered, impervious, leak-proof containers; does not apply to production scrape .................................... (a) Waste containers properly identified ........................................ (b) Storage of garbage/rubbish meets requirements ...................... (c)

16. MATERIALS FOR CONSTRUCTION OF CONTAINERS AND CLOSURES
Materials from approved source ................................................ (a) Food-grade lubricants used on contact surfaces; stored to prevent cross contamination; storage clean and ventilated .............................................................................. (b) Containers or materials on floor not used .................................. (c)

4. LIGHTING AND VENTILATION
Adequate light in all rooms ....................................................... (a) Ventilation sufficient ................................................................. (b) Pressure ventilation systems properly filtered........................... (c)

12. PERSONNEL - PRACTICES
Hands washed as required .......................................................... (a) Clean outer garments; hair restraints ....................................... (b) No person affected by disease in a communicable form; while a carrier of such disease; or with inadequately protected wounds or lesions shall work in the fabrication areas .......... (c) Tobacco use in authorized areas only ....................................... (d) Insecured jewelry not permitted in fabrication areas ................ (e)

17. WAXES, ADHESIVES, SEALANTS, COATINGS AND INKS
Handled and stored to prevent cross contamination with non-food-grade materials; storage areas clean and ventilated .............................................................................. (a) Unused materials covered, labeled and properly stored ............ (b) Nontoxic; imparts no flavor or odor; non-contaminating; complies with 21 CFR Parts 175-178 ................................... (c) Transfer containers clean; covered, properly identified.............. (d) Waxing, when used, performed as required; wax kept at proper temperature ............................................................... (e)

5. SEPARATE ROOMS
Fabrication areas separate from non-fabrication areas when required ...................................................................... (a) Regrinding plastic and paper trim shredding, packaging and baling conducted in separate room(s) from fabrication areas or as Appendix J permits .......................... (b)

13. PROTECTION FROM CONTAMINATION
Product contact surfaces protected; all materials in process properly protected ....................................................... (a) Air under pressure directed at materials or product contact surfaces in compliance ............................................ (b) Air directed at materials or product contact surfaces by fans or blowers in compliance ........................................ (c) Pesticides approved; EPA registered ........................................ (d) Pesticides used in accordance with directions; precludes contamination of containers/closures .................. (e) Single-service articles in process protected from contamination ....................................................................... (f) Equipment cleaned after use of non-food-grade materials ........ (g) Cross contamination with non-food-grade material prevented ................................................................................................ (h) No overcrowding of equipment and operations ......................... (i) Toxic chemicals separated from raw materials and finished products .................................................................. (j) Food containers manufactured by facility not used for storage of miscellaneous items or chemicals ................... (k)

6. TOILET FACILITIES-SEWAGE DISPOSAL
Disposal of sewage; other waste; in public sewage system or in compliance with Local and State Regulations ........... (a)
All plumbing complies with Local and State plumbing Regulations .......................................................................... (b) Solid, tight-fitting, self-closing doors ........................................ (c) Toilet rooms and fixtures clean; in good repair ........................ (d) Adequate light and ventilation; ducts vented to the outside ...... (e) Proper handwashing facilities ................................................... (f) Open windows effectively screened .......................................... (g) Employee handwashing signs posted ....................................... (h) Eating/food storage prohibited .................................................. (i)

18. HANDLING OF CONTAINERS AND EQUIPMENT
Handling of container and closure surfaces minimized ............. (a) Hands sanitized frequently or clean, single-use gloves worn; sanitizing dispensers convenient ................................ (b)

19. WRAPPING AND SHIPPING
Single-service articles properly containerized prior to shipping ............................................................................... (a) Packaged contents protected from contamination .................... (b) Transportation vehicles clean; in good repair; not used for unapproved uses ..................................................... (c) Paperboard containers, wrappers and dividers not reused .................................................................................. (d) Packaging materials in compliance ........................................... (e)

7. WATER SUPPLY
Safe; complies with bacteriological and construction requirements ........................................................................ (a) No direct or indirect connection between safe and unsafe water ........................................................................ (b) Sampled and examined as required .......................................... (c) Recirculated cooling water complies with bacteriological standards, tested semi-annually .......................................... (d) Testing records maintained as required .................................... (e)

20. IDENTIFICATION AND RECORDS
Plant identification on outer wrapping as required .................... (a) Glass containers properly labeled ............................................. (b) Required bacteriological tests on file; maintained as required; and in compliance ................................................. (c) Required bacteriological and chemical test records for all component parts used in final assembled product on file .................................................................................... (d) Information on file from suppliers of raw materials, waxes, adhesives, sealants, coatings and inks indicating compliance ........................................................................... (e) Information on file from suppliers of packaging materials indicating compliance ............................................................ (f)

14. STORAGE OF MATERIALS AND FINISHED PRODUCT
Away from any wall; soiled outer turns or edges discarded ...... (a) Stored in clean, dry place, protected from splash, insects, and dust .............................................................................................. (b) Containers and closures stored in original cartons and sealed until used; partially used cartons resealed during storage ............................................................................................ (c) Containers for storage of resin, raw and reuse materials are covered, clean, impervious and properly identified ........ (d) In-process storage bins that touch the product contact surface constructed of cleanable, nonabsorbent material; clean ...................................................................... (e)

8. HANDWASHING FACILITIES
Hot and cold and/or warm running water, soap, individual towels or air dryers convenient to fabrication areas; covered trash containers when required; hand sanitizers used as Appendix J permits ................................................. (a) Handwashing facilities clean ..................................................... (b)

9. PLANT CLEANLINESS
Floors, walls, ceilings, overhead beams, fixtures, pipes and ducts clean in rooms as required .................................. (a) Plant free of evidence of insects, rodents and birds ................. (b) Machines and appurtenances clean .......................................... (c)

15. FABRICATING EQUIPMENT
Contact surfaces clean; milk plant equipment utilized for preforming containers clean and sanitized prior to operation ............................................................................. (a)

21. SURROUNDINGS
Surroundings neat and clean and free of breeding areas, conditions attracting or harboring flies, insects or rodents ................................................................................. (a) Driveways graded; no standing water ........................................ (b)

REMARKS (If additional space is required, please place information on the back of this Form or on a separate page.)

DATE

SANITARIAN/CONSULTANT

NOTE: This Form has been developed for use with Appendix J of the Grade "A" Pasteurized Milk Ordinance.

FORM FDA 2359c (10/08)

PREVIOUS EDITION IS OBSOLETE

PSC Graphics (301) 443-1090

EF