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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fresh Mushroom Farm Inc 8/30/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Kansas City District
Southwest Region
11630 West 80th Street
Lenexa, Kansas 66214-3340
Telephone:    (913) 752-2100

 

August 30, 2012
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
Ref. KAN 2012-014
 
Mr. Constantine J. Parato, Owner
Fresh Mushroom Farm, Inc.
2301 Cook Road
Imperial, MO 63052
 
Dear Mr. Parato:
 
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located at 2301 Cook Road, Imperial, MO 63052 on August 15 & 17, 2012. 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 manufactured 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 rodent activity in, on and near product in the food re-packing and storage areas of your facility. For example, our investigator observed the following:
 
A.    Approximately 20 rodent excreta pellets were observed on top of a bag of red kidney beans located near the Northeast corner of your storage barn. The pellets appeared to be fresh and adhered to the tweezers upon collection.
 
B.    (b)(4) boxes of dried mushroom products located approximately five feet from the Southeast corner of your product storage barn were observed to have rodent-like gnaw marks, which penetrated to the interior of the boxes. The rodent-like gnaw marks were approximately two to three inches in length.
 
C.    Approximately 10 rodent excreta pellets were observed on the East side of the product packing table in your food re-packing area.
 
D.    Approximately 10 rodent excreta pellets were observed on the top of a (b)(4) lb box of (b)(4) Sticky Rice on the metal rack in the center of your food re-packing area. Approximately 25 rodent-like urine stains were observed to fluoresce under a black light on the top of the cardboard box.
 
E.    Rodent-like excreta pellets too numerous to count were observed on product shelves on the North and East sides of your re-packing area next to cardboard boxes of product.
 
F.    One dead rodent was observed along the South wall of your food re-packing area, on top of a pile of rodent-like nesting material.
 
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 following:
 
A.    Grass and weeds were observed to be overgrown around your product storage barn.
 
B.    Grass and weeds were observed to be overgrown near your food repackaging area (basement).
 
3. Your firm failed to provide adequate and convenient hand washing facilities where appropriate, as required by 21 CFR 110.37(e). Specifically, there is no hand washing sink in your food re-packing area that enables employees to wash their hands as necessary to protect against contamination.
 
4. Your firm failed to have an adequately maintained plumbing system, as required by 21 CFR 110.37(b). Specifically, our investigators observed standing water on your food re-packing area. The source of this standing water was a damaged drain system in this area.
 
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: Patrick Wisor, Compliance Officer, U.S. Food and Drug Administration, Kansas City District Office, 11630 W. 80th Street, Lenexa, KS 66214. If you have any questions, please do not hesitate to call CO Wisor at (913)752-2730 or send him an email at patrick.wisor@fda.hhs.gov.
 
                                                                       
Sincerely,
/S/ 
John W. Thorsky
District Director
Kansas City District Office