Inspections, Compliance, Enforcement, and Criminal Investigations

Appel Feinkost GmbH & Co. KG 6/1/17

 

  

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5001 Campus Drive
College Park, MD  20740 

 

WARNING LETTER
JUN 1, 2017
 
VIA EXPRESS DELIVERY
 
Wolfgang Lucht, Plant Manager
Appel Feinkost GmbH & Co. KG
Neufelder Schanze 2
Cuxhaven, Lower Saxony, 27472 Germany
 
Reference # 524654
 
Dear Mr. Lucht:
 
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned seafood processing facility located at Neufelder Schanze 2, Cuxhaven, Lower Saxony, 27472, Germany, on February 7-8, 2017. That inspection revealed serious violations of the low-acid canned food regulations (LACF), Title 21, Code of Federal Regulations, Parts 108 and 113 (21 CFR 108 and 21 CFR 113); and violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21 Code of Federal Regulations, Part 123 (21 CFR 123). The inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response received via email on February 22, 2017, which includes a description of corrections to all of the observations noted on FDA-483.  However, your response did not adequately address the deviations related to both your LACF and HACCP operations, as further explained in this letter.
 
LACF operations:
 
As a manufacturer of LACF, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the federal regulations relating to the processing of LACF products you export to the United States. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers.  As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.35 and 21 CFR 113 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. § 344).  As stated in 21 CFR 108.35(k), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. § 381) when offered for entry into the United States. Consequently, your violations of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR 113 render your LACF products adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)]. You can find the Act and the low-acid canned food regulations through links in FDA’s home page at www.fda.gov.
 
Your significant LACF violations are as follows:
 
1.    Your firm failed to process each low-acid canned food in conformity with at least the scheduled process, as required by 21 CFR 108.35(c)(3)(i). Specifically, on February 7, 2017, our investigator observed, during the (b)(4) processing step of your firm’s production of Herring Fillets in Tomato Sauce, the minimum come-up time of (b)(4) minutes and the minimum processing time of (b)(4) minutes, as listed in your scheduled process, were not met. In practice, you actually only completed a (b)(4) minute minimum come-up time and (b)(4) minute processing time, as listed in a scheduled process provided by Ellab on May 6, 2014. We have reviewed your response received via email on February 22, 2017 and we acknowledge that you state, “Update SID,” to be implemented in June 2017. However, there is no information provided regarding the adequacy of the process that was observed in achieving commercial sterility. Moreover, you have not provided the parameters for the new scheduled process you intend to file.
 
2.    Your firm did not determine and record with sufficient frequency the initial temperature of the contents of the containers to be processed to ensure the temperature of the product was no lower than the minimum initial temperature specified in the scheduled process, as required by 21 CFR 113.87(c). Specifically, on February 7, 2017, our investigator observed during the (b)(4) processing step of Herring Fillets in Tomato Sauce, you did not measure the initial temperature on the coldest can before initiating the (b)(4) cycle. We have reviewed your response received via email on February 22, 2017 and we acknowledge your response in which you state, “The records of the (b)(4) process are added”. This response is not adequate because you have not provided information regarding the adequacy of the process that was observed during the inspection in achieving commercial sterility.
 
3.    Your firm did not specify a critical factor that may affect the scheduled process, as required by 21 CFR 113.83. Specifically, on February 7-8, 2017, our investigator observed that your scheduled process for Herring Fillets in Tomato Sauce did not include monitoring of the maximum fill weight during the filling of cans with sauce and herring as a critical factor. We have reviewed your response received via email on February 22, 2017 and we acknowledge your response in which you state, “Update SID,” to be implemented in June 2017. However, this proposed implementation date does not constitute a timely corrective action.
 
4.    Your firm failed to have personnel involved in (b)(4) processing systems and container closure inspections under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner, as required by 21 CFR 108.35(g). Specifically, there is no person at the Cuxhaven facility that has completed the Better Process Control School (BPCS) at this time. We acknowledge that your February 22, 2017 response states that an individual of the Cuxhaven facility will take part in a BPCS in 2017; however, your firm did not identify a specific date and name of a certified BPCS and you continue to operate without supervision of a person who has satisfactorily completed the training.
 
5.    Your firm did not include the product, code number, approximate number of containers per coding interval, initial temperature and actual processing time on processing and production information forms, as required by 21 CFR 113.100(a). Specifically, your hand written processing records do not include the required processing information in order for your firm to adequately review the (b)(4) process. We acknowledge your response dated February 22, 2017 which states, “The processing records of the (b)(4) process were added,” to be implemented by 07/31/2017. ”. This response is not adequate because you have not provided information related to the required processing information to ensure that you can assess that each lot of product achieved commercial sterility.
 
Seafood HACCP operations:
 
As a manufacturer of fish and fishery products, failure to have an implement a HACCP plan that complies with 21 CFR 123.6(g) or otherwise operate in accordance with the requirements of Part 123 renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)). Accordingly, review of your HACCP plan reveals that your canned herring fillet products are adulterated in that they have been prepared, packed or held under conditions whereby they may have been rendered injurious to health.

You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links in the FDA’s home page at www.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our website at: www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm.
 
Your significant seafood HACCP violation is as follows:
 
1.    You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR.6(a) and  (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your HACCP plan titled, “HACCP inspection plan for all products” for your canned herring fillet products does not list the scombrotoxin (histamine) formation as a hazard. Although prerequisite programs provide adequate safety controls for LACF products, The seafood HACCP regulation requires that all reasonably likely food safety hazards be identified and that controls be in place through an adequate HACCP plan. We have reviewed your response received via email on February 22, 2017 where you stated, “(b)(4),” to be implemented by August 31, 2017. However, your response is not complete without providing us evidence that your corrections have been completed and implemented.    
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You should include in your response documentation, such as at least five (5) days of production records, to demonstrate that you have implemented the revisions indicated in your response and any other useful information that would assist us in evaluating your corrections. Responding in English will help to assist us in our review of your documentation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
If you do not respond to this letter or if we find your response inadequate, we may take further action.  For instance, we may take action to refuse admission of your imported LACF products under section 801(a) of the Act, 21 U.S.C. 381(a), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the LACF and acidified food regulations (21 CFR 108, 113, and 114) is Import Alert #99-38. An example of an import alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120. These import alerts can be found on FDA’s web site at: https://www.accessdata.fda.gov/cms_ia/ialist.html.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the LACF regulations (21 CFR 108 and 113), the Seafood HACCP regulation (21 CFR 123), and the current Good Manufacturing Practices regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
Additionally, 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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign 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 reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Clarice J. Ahn, Compliance Officer, Food Adulteration Assessment Branch, Division of Enforcement, Office of Compliance, Center for Food Safety and Applied Nutrition, HFS-607, 5001 Campus Drive, College Park, MD 20740 U.S.A. You may submit documentation accompanying your reply to: clarice.ahn@fda.hhs.gov. Please include reference No. 524654 on any submissions and within the subject line of any emails to us. You may also contact Clarice J. Ahn via email if you have any questions about this letter. 
 
 
Sincerely,
/S/ 
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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