| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
December 27, 2013
Gary Reichart and Gregory Cox
G and G Peppers
12245 North County Road 450 W
Gaston, IN 47342
Dear Mr. Reichart and Mr. Cox:
The Food and Drug Administration (FDA) inspected your food processing facility located in Gaston, IN from August 20, 2013 through August 29, 2013. The inspection determined your facility produced acidified foods and revealed you have significant deviations from the requirements of the Acidified Food regulations described in Title 21, Code of Federal Regulations (CFR), Part 108, Emergency Permit Control (21 CFR Part 108), and Part 114, Acidified Foods (21 CFR 114). These conditions cause the acidified food products processed and stored at your facility to be 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)] because these products have been prepared, packed, or held under unsanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath. You can find the Act and its associated regulations through links on the FDA webpage at www.fda.gov
As an acidified food processor, you are required to comply with the FD&C Act, and regulations for processing acidified foods and current good manufacturing practices. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the FD&C Act [21 U.S.C. § 344]. A temporary emergency permit may be required for acidified foods whenever a processor fails to fulfill the mandatory requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements within 21 CFR Part 114.
We received your written responses to the Form FDA 483 dated September 17, 2013, October 15, 2013, and November 15, 2013. After reviewing your responses, we continue to have concerns with the following significant observations:
1. As a commercial processor engaged in the processing of acidified foods, you must, not later than 60 days after registration and prior to the packing of a new product, provide FDA information as to the scheduled processes including, as necessary, conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2). However, you failed to file a scheduled process with FDA for the following acidified foods that your firm manufactures: jalapeno peppers, banana peppers, serrano peppers, cherry peppers, and habanero peppers. We acknowledge your attempts to submit a process filing to FDA in 2004 for jalapeno peppers; however, these filings were returned and need to be re-submitted in order to comply with 21 CFR 108.25(c)(2). In addition, these processes must be established by a qualified person who has expert knowledge acquired through appropriate training and experience in the acidification and processing of acidified foods as required by 21 CFR 114.83.
We acknowledge that your firm has worked with your process authority to establish new process parameters so that the maximum equilibrium pH of your acidified food products does not exceed (b)(4) and a (b)(4) is not required. We agree that a pH of (b)(4) is very low and protects the products from the growth of Clostridium botulinum; however, you need to submit your studies and process filing information to FDA through normal procedures as described below. Please note that your process filings need to reflect your firm’s actual processing operations; our investigators observed use of a different rinse and different size totes than what were identified in your returned process filing for jalapeno peppers.
Your firm is responsible for determining which regulations apply to the products that you manufacture, including whether any of your products are considered acidified foods, as defined in 21 CFR 114.3(b), subject to the applicable provisions of 21 CFR parts 108 and 114. Accordingly, your firm should determine or have determined for you whether any additional products that you manufacture are acidified foods, and comply with the applicable requirements of 21 CFR 108 and 114 including registration and process filing.
Scheduled process information for acidified foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods,” available at:
2. Your firm failed to examine containers often enough to ensure that containers suitably protect the food from leakage or contamination as required by 21 CFR 114.80(a)(4). Specifically, on August 20, 2013, the investigators observed finished jalapeno peppers stored in (b)(4) pound totes that contained a white mold-like substance directly on the peppers and on the container. On August 24, 2013, the investigators observed (b)(4) containers consisting of finished jalapeno peppers, cherry peppers, and mild banana peppers that contained a white mold-like substance directly on the peppers and on the container.
We acknowledge that your firm has investigated the root cause of this mold growth and suggests that the oxygen permeability of the barrel liner may be the problem. In addition, we note that you have experimented with a variety of different package types and sealing techniques and shelf life studies; however, you state that your employees continue to follow your Standing Operating Procedure (SOP) for pre-shipment review of every container until a final solution is determined.
Your described corrections actions are not adequate. You have not explained whether you have been able to find an adequate packaging type and seal technique. Container integrity of your package is essential to prevent the growth of spoilage organisms. In addition, molds have been found to raise the pH of products which could allow for the growth of Clostridium botulinum. Because your product does not receive a (b)(4) (b)(4), your product is more susceptible for this type of contamination if container integrity is compromised. Following a pre-shipment SOP to review each container is not a feasible solution and is not an adequate strategy to verify safety of your products.
The above list is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the FD&C Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective action may subject your firm and products to further actions, such as emergency permit control, injunction, or seizure.
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 Section 743(a)(2(B) of the FD&C Act [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 FD&C Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted deviations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long term corrective actions, such as evidence that you are working with a process authority or your scheduled process has been filed with the FDA. If you cannot complete all corrective actions before you respond, we expect that you will explain the reason for your delay and state when you will correct the remaining deficiencies.
Your response should be directed to: Cicely Vaughn, Compliance Officer, U.S. Food and Drug Administration, Detroit District Office 300 River Place, Suite 5900, Detroit, MI 48207-4291. If you have any questions, please do not hesitate to call Compliance Officer Vaughn at (313) 393-8297 or an email to her at Cicely.Vaughn@fda.hhs.gov.
Glenn T. Bass
Detroit District Office