- Fabrica de Conservas A Poveira, S.A.
- Issuing Office:
- Center for Food Safety and Applied Nutrition
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5001 Campus Drive
College Park, MD 20740
MAY 5, 2017
VIA EXPRESS DELIVERY
Mr. Sergio Real, Administrador/Board Member
Fabrica De Conservas A Poveira S.A.
Parque Industrial De Laundos, Lote 46
4510-311 Laundos Povoa De Varzim, Portugal
Reference # 522637
Dear Mr. Real:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your low-acid canned seafood processing facility, Fabrica De Conservas A Poveira S.A., located at Parque Industrial De Laundos, Lote 46, 4510-311 Laundos Povoa De Varzim, Portugal on February 6-7, 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 serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the serious deviations found at the firm. We acknowledge receipt of your response dated February 24, 2017. In your response, you indicate that you have made corrections to the LACF and HACCP deviations observed during the inspection. However, your response did not adequately address the deviations related to both your LACF and your seafood HACCP operations, as further described in this letter.
As a manufacturer of LACF products, you are required to comply with the U.S. Federal 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 Hermitically 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 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 (see additional information elsewhere in this letter).
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 LACF regulations through links in FDA's home page at http://www.fda.gov
1. Your firm failed to identify, from a processor check or otherwise, critical factors that deviated from the filed scheduled process and failed to record these deviations in a separate log, as required by 21 CFR 113.89.
Specifically, on February 6, 2017, the initial temperature (IT) of a can of plain sardines in olive oil was measured by your retort operator at 18.9°C (66.02°F). The product was subsequently (b)(4). The (b)(4). No corrective actions were taken in response to the deviations of the IT and the process time.
Your response, dated February 24, 2017, is not adequate. We acknowledge your statement that the process you “(b)(4)” and that you have provided updated initial temperature calculations, a heat penetration study, and temperature distribution studies; however, you have not filed an updated scheduled process. Your firm needs to revise your scheduled processes accordingly and re-file them with FDA.
2. Your firm failed to measure and record critical factors specified in the scheduled process at intervals of sufficient frequency to ensure that the factors were within the limits specified in the scheduled process, as required by 21 CFR 113.40(b)(15).
Specifically, initial temperature (IT), come up time (CUT), the temperature-indicating device and temperature recording device readings, number of containers per coding interval and the actual process time were not documented on the production record, titled "Esterilizacao." Your response dated February 24, 2017, is not adequate in that the updated production record that you provided still does not have headings pertaining to come up time (CUT), the temperature-indicating device and temperature recording device readings, and number of containers per coding interval where these critical factors can be recorded during retort operations. Furthermore, you only provided a blank production record so we cannot verify that you are recording initial temperature and the actual process time.
Seafood HACCP operations
As a manufacturer of fish and fishery products, failure of a processor of fish or fishery products to have and 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 Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your canned sardines, mackerel, and codfish products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
Your significant seafood HACCP deviations are as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards identified, to comply with 21 CFR 123.6(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 firm’s HACCP plan for canned sardines, mackerel, and codfish does not list the food safety hazards of:
- Scombrotoxin (histamine) formation associated with your sardines and mackerel, which are scombrotoxin forming species. Scombrotoxin is a heat stable toxin resulting from time and temperature abuse of the fish that is not eliminated (b)(4);
- Staphylococcus aureus growth and toxin formation. Staphylococcal enterotoxin is a heat stable toxin resulting from time and temperature abuse of the fish following a precook step that is also not eliminated (b)(4).
During our inspection, we noted multiple processing steps where these hazards are reasonably likely to occur in the absence of controls, specifically:
While you list (b)(4) in your hazard analysis, prerequisite programs such as GMPs and sanitation cannot replace HACCP plan controls. 21 CFR 123.6(c)(1) requires that all food safety hazards identified in a hazard analysis be listed and addressed in a HACCP plan.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these deviations. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan, five (5) consecutive days of completed Seafood HACCP monitoring records and LACF production records (i.e., complete sets for the production of 5 production date codes of products) 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. 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.
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 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 the re-inspection fees (21 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
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 regulations (21 CFR Parts 108 and 113) 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.fda.gov/forindustry/importprogram/actionsenforcement/importalerts/default.htm
Please send your reply to the U.S. Food and Drug Administration, Attention: Kerry Kurdilla, 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: firstname.lastname@example.org. Please reference CMS# 522637 on any submissions and within the subject line of any emails to us. You may also contact Kerry Kurdilla via email if you have any questions about this letter.
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition