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  5. Fitkin Popcorn LLC - 10/16/2014
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WARNING LETTER

Fitkin Popcorn LLC Oct 16, 2014

Fitkin Popcorn LLC - 10/16/2014


Recipient:
Fitkin Popcorn LLC


United States

Issuing Office:
Kansas City District Office

United States


  

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

Public Health Service
Food and Drug Administration
 Kansas City District
Southwest Region
8050 Marshall Dr., Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100 

October 16, 2014

UPS NEXT DAY AIR

WARNING LETTER

Ref. CMS# 441027
 

Mr. James S. Fitkin, Owner
Fitkin Popcorn LLC
5400 Ford Rd.
Cedar Falls, lA 50613

Dear Mr. Fitkin:

The Iowa Department of Inspections and Appeals (DIA), under contract on the behalf of the United States Food and Drug Administration, inspected your manufacturing facilities located at 5400 Ford Rd, Cedar Falls, IA 50613 and 3701 Ford Rd, Cedar Falls, IA 50613 on September 22, 2014. 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 facilities 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.

The September 22, 2014 inspection was a follow-up to a previous DIA inspection, under contract on the behalf of the U.S. Food and Drug Administration, of your facilities on September 8, 2014. The September 8, 2014 inspection found significant CGMP violations, including: failure to take effective measures to exclude pests from processing areas and to protect against the contamination of food on the premises by pests; failure to use cleaning compounds and sanitizing agents which are safe and adequate under the conditions of use; failure to properly hold pesticide chemicals in a manner that protects against contamination of food; failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination; failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food. We acknowledge that DlA provided you with approximately 2 weeks to correct the observed GMP deficiencies.

DIA inspection of you facilities on September 22, 2014 revealed the following CGMP violations including repeat violations from the September 8, 2014 inspection:

1.    Your firm failed to take effective measures to exclude pests from processing areas and protect against the contamination offood on the premises by pests as required by 21 CFR 110.35(c).
Specifically, on September 22, 2013, the following was observed as evidence of pest infestation:

a.    Apparent rodent and bat droppings on the floor of the storage building located at the 5400 Ford Rd. facility where (b)(4) paper bags of popcorn and packaging materials are stored.
b.    Apparent rodent droppings on the wood beam next to the lower end of the transfer auger between the gravity table and the bulk storage bin in the building at the 3701 Ford Rd. facility. This transfer auger carries popcorn directly into a storage bin which is used to directly fill (b)(4) paper bags of popcorn which can be sold directly to the customer.
c.    Apparent rodent droppings and an insect in the popcom product at the lower end of the transfer auger between the gravity table and the bulk storage bin in the building at the 3701 Ford Rd. facility. This transfer auger carries popcorn directly into a storage bin which is used to directly fill (b)(4) paper bags of popcorn which can be sold directly to the customer.

2.    Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). The Inspector observed the following:

a.    An opening to the exterior, which allows entry of pests, at the base of the door at the SE corner of the building located at the 3701 Ford Rd. facility where popcorn is sifted, cleaned, and packaged into (b)(4) paper bags which can be sold directly to the customer.
b.    An opening to the exterior, which allows entry of pests, at the base of the large sliding door on the West side of the building located at the 3701 Ford Rd. facility where popcorn is sifted, cleaned, and packaged into (b)(4) paper bags which can be sold directly to the customer.
c.    An opening to the exterior, which allows entry of pests, at the base of the lower SW corner of the building located at the 3701 Ford Rd. facility where popcorn is sifted, cleaned, and packaged into (b)(4) paper bags which can be sold directly to the customer.

3.    Your firm failed to provide hand washing facilities at the bulk storage facility, where popcorn is sifted, cleaned, and packaged into (b)(4) paper bags which can be sold directly to the customer, as required by 21 CFR 110.37(e)(1).

In addition to the CGMP deviations, our records indicate your firm located at 3701 Ford Rd, Cedar Falls, IA 50613 is (b)(3)

This letter may not list all the violations at your facility. You are responsible for ensuring 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.

Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting there-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Your response should be directed to: Andrew A. Hoopes, Compliance Officer, U.S. Food and Drug Administration, Kansas City District Office, 210 Walnut St., Suite 369, Des Moines, LA 50309. If you have any questions, please do not hesitate to call CO Hoopes at (515) 244-0480 ext. 1002 or send him an email at andrew.hoopes@fda.hhs.gov.
 

Sincerely,
/S/
Cheryl A. Bigham
District Director
Kansas City District Office
 

cc: Iowa Department of Inspections and Appeals
Food and Consumer Safety Bureau
312 E. 12th St., Floor 3
Des Moines, IA 50319-0083