Inspections, Compliance, Enforcement, and Criminal Investigations

Orangeburg Pecan Company Inc 5/17/18

 

  

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U.S. Food & Drug Administration
Office of Human and Animal Foods
Division III East
60 Eighth Street N.E.
Atlanta, GA 30309

May 17, 2018

VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED

Frederick J.D. Felder, President
Orangeburg Pecan Company, Inc.
761 Russell St.
Orangeburg, SC 29115-5819

Reference: CMS Case # 544396

WARNING LETTER

Dear Mr. Felder:

The U.S. Food & Drug Administration (FDA) inspected your ready-to-eat (RTE) pecan processing facility from October 17, 2017 through November 16, 2017 for compliance with subpart B (Current Good Manufacturing Practice) of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). That inspection revealed serious violations of subpart B of the CGMP & PC rule. 

During this inspection, the investigator collected sample INV1014991 from two pieces of production equipment located in your production room.  FDA analysis of this sample confirmed the presence of rodent excreta pellets in your facility.  Based on FDA’s analytical results for the sample and inspectional findings documented during the inspection, we determined that your RTE pecan products are 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 have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health.   You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov.

The inspection resulted in FDA’s issuance of an FDA Form-483, Inspectional Observations (FDA-483), listing the deviations found at your firm at the conclusion of the inspection.  We acknowledge your firm’s corrections made during the inspection including cleaning equipment and some repairs; however,  other deviations were either not addressed or inadequately addressed as outlined in this letter.  To this date, a written response to the FDA-483 was not received from your firm describing the status of the promised corrections and how the corrections you have taken will be sustained to prevent recurrence.

FDA investigators observed the following significant violations of the Current Good Manufacturing Practice requirements in subpart B:

1. You did not exclude pests from your food plant to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, during the inspection of your facility, an FDA investigator noted evidence of insect and rodent activity in your facility.  For example, our investigator observed rodent excreta pellets and dead insect parts on and around the pecan dryers, including food contact surfaces, in the north room. Our investigator also observed live cockroaches on the wall in the north room of the plant where empty barrels are stored and next to the bay door in the toasting room. Furthermore, FDA sample INV1014991 confirmed the presence of rodent excreta pellets in your facility.

2. All person working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR 117.10(b).  However, our investigator observed employees touching shelled pecans with bare hands that were not washed after touching non-food contact surfaces such as doors and stools. 

3. You must clean all food-contact surfaces, including your utensils and food-contact surfaces of equipment, as frequently as necessary to protect against contamination of food, as required by 21 CFR 117.35(d).  However, our investigator observed an accumulation of dirt, grime, and debris on food contact surfaces of all pecan dryers in the facility.  In addition, throughout the inspection, the inside surfaces of the green barrels used to store shelled pecans were visibly dirty with grime build up. You informed our investigator during the inspection that the barrels are only cleaned once per month.
 

4. You must ensure that seams on food-contact surfaces are smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms, as required by 21 CFR 117.40(b).  However, our investigator observed rough welds with apparent visible grime and pecan debris on all pecan dryers. 
 

5. You must maintain buildings, fixtures, and other physical facilities of your plant in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a).   However, our investigator observed several air gaps around the frame of the bay door in the north room and a gap between the roof and the wall located on the north side of the building.  The investigator also observed a vent fan in the south drying room covered by a metal screen that was completely open at the top and broken on the lower front, middle section of the metal screen. 

These gaps allow rodents and other pests to access areas where food is stored and processed. 

During the close-out discussion with the investigator, you also promised to install wire for vent screening and replace the rubber on the bay door of the north room within the next three months. However, you have not provided a response to the FDA 483 describing the status of the promised corrections or how the corrections you have taken will be sustained to prevent recurrence.

Unsafe Food Additive

Our investigator documented that a chemical labeled “BioGuard maintain CLC3 swimming pool multi-purpose granular chlorine” is used by your firm as a hand dip, as a pecan meat wash, and as an overnight soak of in-shell pecans prior to cracking.  These are food additive uses (see definition of a food additive in section 201(s) of the Act (21 USC § 321(s))) because there is a reasonable expectation that these uses will result in the chlorine compound migrating into your pecans.  As such, “BioGuard maintain CLC3 swimming pool multi-purpose granular chlorine” is an unsafe food additive under Section 409(a) of the Act (21 USC § 348(a)) because it is not covered under one of the following, and as such is not authorized for use in contact with food:

1. A regulation that provides for its safe use;
2. A GRAS (Generally Recognized as Safe) regulation, GRAS notice or otherwise meeting the criteria for generally recognized as safe GRAS;
3. A prior sanction letter issued by FDA or the United States Department of Agriculture prior to September 6, 1958;
4. Threshold of Regulation (TOR) exemption in accordance with 21 CFR 170.39; or
5. An effective Food Contact Substance Notification (FCN).

This letter may not list all the deviations at your facility.  You are responsible for ensuring that your food facility operates in compliance with the Act and all applicable regulations, including the CGMP & PC rule.  You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.  
 

Note that, although not covered by this inspection, you are subject to the preventive control requirements (primarily located in subparts C and G) of the CGMP & PC rule.   Under those requirements, a covered food facility must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held by the facility will not be adulterated under section 402 or misbranded under section 403(w) of the Act (21 USC §§ 342 and 343(w)).   Further, a covered food facility must have a written food safety plan that includes a written hazard analysis, and written preventive controls that are appropriate to the facility and food (i.e., process controls, food allergen controls, sanitation controls, recall plan, and a supply chain program as necessary).  Other requirements include employee training (subpart A) and recordkeeping (subpart F). Exemptions (21 CFR 117.5) and modified requirements (subpart D) are applicable to certain operations.

Section 743 of the 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 Act, specifically to determining 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 noncompliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any re-inspection-related costs.

To date we have not received a response from you. You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 4600 Goer Drive, #106, North Charleston, SC 29406. If you have any questions about this letter, please contact Compliance Officer King at (843) 746-2990 x16 or via email at janice.king@fda.hhs.gov.
 
Sincerely,
/S/
Ingrid A. Zambrana
District Director
U.S. Food & Drug Adminisration
FDA Atlanta District
Office of Human and Animal Foods- Division 3 East
(Georgia- North Carolina-South Carolina)
Office of Regulatory Affairs
 

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