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CLOSEOUT LETTER

Pearson Foods Inc. MARCS-CMS 506517 —


Recipient:
Recipient Name
David C. Pearson
Pearson Foods Inc.

1024 Ken-O-Sha Industrial Park Drive, SE

Grand Rapids, MI 49508-8217
United States

Issuing Office:
Detroit District Office

United States


  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

 

WARNING LETTER
2017-DET-01
 
 
October 26, 2016
 
 
VIA UPS
 
 
Mr. Eric W. Pearson, President
Pearson Foods, Inc.
1024 Ken-O-Sha Industrial Park Drive, SE
Grand Rapids, MI 49508-8217
 
 
Dear Mr. Pearson:
   
The U.S. Food and Drug Administration (FDA) inspected your ready-to-eat cut fruit and vegetable processing facility located at 1024 Ken-O-Sha Industrial Park Drive, SE, Grand Rapids, MI between June 14 and 27, 2016. During our inspections, FDA investigators observed violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).[1] Based on FDA’s inspectional findings documented during the inspection, we determined that your food products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 342(a)(4), in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Food Drug and Cosmetic Act and FDA’s regulations through links on FDA’s home page at www.fda.gov
 
Good Manufacturing Practices
 
FDA investigators observed serious violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]. Your significant violations were as follows:
 
1.    You must provide adequate floor drainage in all areas where normal operations release or discharge water or other liquid on the floor in order to comply with 21 CFR 110.37(b)(4). However, we observed standing water during the production of shredded cabbage. There was food debris on the floor in the standing water and workers walked through the water. Standing water fosters harborage of pathogens such as Listeria monocytogenes
 
2.    Your plant must be constructed in such a manner that floors may be adequately cleaned, kept clean, and kept in good repair in order to meet the requirements of 21 CFR 110.20(b)(4). However, the cement floors in your processing area are pitted and eroded, creating a harborage for microorganisms.  
 
3.    Your plant must also be constructed in such a manner that condensate from fixtures doesn’t contaminate food in order to meet the requirements of 21 CFR 110.20(b)(4). However, on June 14, 2016 investigators observed condensation on two metal plates and on a conduit wire above unprotected ready-to-eat coleslaw.
 
4.    Your plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained in order to meet the requirements of 21 CFR 110.40(a). However, there were deep gouges along the entire length of the cutting table belt. In addition, cutting boards contained deep gouges intentionally cut into the boards to serve as a means of measurement. These conditions cause these surfaces to be difficult to maintain clean and sanitary.  
 
In your June 20, 2016 email response to the investigator’s observations, you stated that you had either completed or started to replace the belt, replace the floor, and implement hose training. We will evaluate the adequacy of your corrective action during our next inspection.
 
This letter is not intended to be an all-inclusive statement of the violations that exist at your firm. You are responsible for ensuring that your firm is operating in compliance with all the requirements of the FD&C Act, and all applicable regulations, including the Current Good Manufacturing Practice regulation [21 CFR Part 110]. Your firm should take prompt action to correct the violations addressed in this letter. You also have a responsibility to use procedures to prevent further violations of the FD&C Act and all applicable regulations.
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. In your response include documentation or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Section 743 of the FD&C Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s 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 FD&C 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 the re-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 non-compliance materially related to a food safety requirement of the FD&C Act. Accordingly, FDA may assess fees to cover re-inspection-related costs.
 
Your firm’s response should be sent to: Cicely Vaughn, Compliance Branch, Food and Drug Administration, District Office, 300 River Place Suite 5900 Detroit, MI 48207. If you have any questions about the contents of this letter, please contact: Cicely Vaughn, Compliance Officer, at 313-393-8297 or cicely.vaughn@fda.hhs.gov.
  
 
Sincerely,
/S/ 
Art Czabaniuk
District Director
Detroit District Office
 

[1] Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (CGMP & PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size.   See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for CGMP & PC rule compliance dates.
 
 
 
 

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