Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100
August 28, 2013
RETURN RECEIPT REQUESTED
Ref. KAN 2013-15
Mr. John Paul Muelhaupt, Owner
Mason City Cold Storage Company
633 15th St SE
Mason City, IA 50401-5933
Dear Mr. Muelhaupt:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located 633 15th St SE, Mason City, IA 50401 on August 6 & 7, 2013. The inspection found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the foods stored at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the Act and its implementing regulations on FDA’s home page www.fda.gov.
Specifically, our inspection of your facility revealed the following CGMP violations:
1. Your firm failed to take effective measures to exclude pests from processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). There was evidence of widespread pest activity in, on and near product in the food storage areas of your facility. For example, our investigators observed the following:
- Apparent excreta pellets (AEP) too numerous to count (TNTC) in dry storage room 4-5 were observed on and around:
Quick Rolled Oats #21, lot (b)(4), pallet B1065895, approximately (b)(4)lb bags, manufactured by (b)(4) pallets
All Purpose Flour, Mason City Cold Storage lot (b)(4), distributor lot 1008, manufactured by (b)(4)
- 5 AEP on (b)(4) Elbow Macaroni mfg date 092311, (b)(4) pallets
- 3 AEP on (b)(4) Vegetable Oil, (b)(4) pallets
- 5 AEP on top of (b)(4) fat free refried beans, (b)(4), lot (b)(4)
- AEP TNTC were also observed on the floor along the south wall adjacent to a hole in the wall adjoining a cold storage and the dry storage room as well as another hole in the wall adjacent to the exterior of the facility
- AEP TNTC were observed on the wall in the pallet storage room and on the floor up against the wall. This wall has numerous holes with exposed insulation and AEP directly below and leading from the holes in cracks along the wall.
- Two bats were observed hanging from the ceiling in dry storage room 4 directly over lots of all-purpose flour lots (b)(4) and (b)(4).
2. Your firm failed to properly cut weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 110.20(a)(1). For example, our investigator observed the grass and weeds to be overgrown around the new freezer building.
3. Your firm failed to maintain buildings and physical facilities in sufficient repair to prevent food from becoming contaminated, as required by 21 CFR 110.35(a). Specifically, during the inspection of the interior of the building, in the pallet storage room, the investigators observed at least 5 holes in the wall with exposed insulation. In this room, the investigators also observed a storage space with a wooden box containing out of use equipment and components as well as refuse.
Additionally, in room 5 the investigators observed a large gap in the metal siding of the wall adjacent to ambient dry food storage. Along the perimeter wall, visible for at least 5 feet, Investigator observed an approximately 3 inch deep gap between the metal siding and the concrete floor.
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products, injunction and/or prosecution.
We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter. Your response should include the specific steps you have taken to correct the violations. If you can not complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Your response should be directed to: Danial Hutchison, Compliance Officer, U.S. Food and Drug Administration, Kansas City District Office, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214. If you have any questions, please do not hesitate to call CO Hutchison at (913)495-5154 or send him an email at Danial.Hutchsion@fda.hhs.gov.
John W. Thorsky
Kansas City District Office