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WARNING LETTER

Wilbo S.A. MARCS-CMS 532776 —

Recipient:
Wilbo S.A.

United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States

 

  

Black HHS-Blue FDA Logo

 

5001 Campus Drive
College Park, MD 20740
 

 
 

WARNING LETTER

AUG 8, 2017

VIA EXPRESS DELIVERY

Mr. Grzegorz Biatoruski, President of the Board
Wilbo S.A.
UI. Hutnicza 22
Gdynia, Pomorskie, 81-061 Poland

Reference # 532776

Dear Mr. Grzegorz Biatoruski:

The U.S. Food and Drug Administration (FDA) inspected your low-acid canned seafood processing facility located at UI. Hutnicza 22, Gdynia, Pomorskie, 81-061 Poland, on March 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 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 a FDA-483, lnspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response received via email on March 20, 2017, which included 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 products, 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 of LACF products 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 21CFR108.35(c)(3)(i). Specifically, on March 7, 2017, our investigator reviewed your firm's scheduled processes for Salmon and Tuna Salad in Tomato Sauce with Vegetables and the corresponding processing records, and observed the following:

a.  Your scheduled process for manufacturing Sa lmon Salad in Tomato Sauce with Vegetables in size 305 x 108 metal cans identifies a minimum processing temperature of (b)(4) and a minimum processing time of (b)(4) minutes. This scheduled time and temperature were not met during the processing of Salmon Salad in Tomato Sauce with Vegetables on the following dates: May 26, 2015; March 10, 2016; and January 24, 2017. The product was processed at (b)(4) for (b)(4) minutes on all three of the above-mentioned dates.

b.  Your scheduled process for manufacturing Tuna Salad in Tomato Sauce with Vegetables in size 305 x 108 metal cans identifies a minimum processing temperature of (b)(4) and a minimum processing t ime of (b)(4) minutes. This scheduled time and temperature were not met during the processing of Tuna Salad in Tomato Sauce with Vegetables on the following dates: April 27, 2016; October 13, 2016; January 20, 2017; and January 24, 2017. The product was processed at (b)(4) for (b)(4) minutes on all four of the above-mentioned dates.

c.  Your scheduled process for manufacturing Salmon Salad in Tomato Sauce with Vegetables in size 305 x 108 metal cans identifies a maximum fill weight of (b)(4) The net weight of Salmon Salad in Tomato Sauce with Vegetables exceeded this maximum fill weight on the following dates: May 26, 2015 (6 out of 30 cans); March 10, 2016 (7 out of 30 cans); and January 24, 2017 (2 out of 30 cans).

d. Your scheduled process for manufacturing Tuna Salad in Tomato Sauce with Vegetables in size 305 x 108 metal cans identifies a maximum fill weight of (b)(4) The net weight of Tuna Salad in Tomato Sauce with Vegetables exceeded this maximum net weight on the following dates: April 27, 2016 (1 out of 30 cans); October 13, 2016 (2 out of 30 cans); January 20, 2017 (5 out of 30 cans); and January 24, 2017 (5 out of 30 cans).

We have reviewed your response received via email on March 20, 2017, in which you state your firm will (b)(4) included in "report no. 10/2016/W, Heat Penetration Test" to meet the filed minimum processing temperatures and times for both Salmon Salad in Tomato Sauce with Vegetables and Tuna Salad in Tomato Sauce with Vegetables. In addition, to meet the scheduled maximum fill weight, you stated you will "adjust the required max and min levels to the US guidelines." Your response is not adequate because we did not receive "report no. 10/2016/W, Heat Penetration Test." You did not indicate whether you would update your scheduled processes, or file new ones based on the referenced study. Lastly, you did not indicate whether any corrective actions are/were taken on products not processed in accordance with your scheduled processes.

2.    Your firm failed to obtain substantiation by a qualified scientific authority as to the adequacy of any intentional change in a previously filed scheduled process, where the change is basic to the adequacy of that scheduled process, as required by 21 CFR 108.35(c)(2)(ii). Specifically, On March 7, 2017, our investigator reviewed processing records and observed that your firm routinely processes Salmon Salad in Tomato Sauce with Vegetables and Tuna Salad in Tomato Sauce with Vegetables, both in size 305 x 108 metal cans, at a processing temperature of (b)(4) for (b)(4) minutes. However, the current scheduled processes for these products identify a minimum processing temperature of (b)(4) and a minimum processing time of (b)(4) minutes.

We have reviewed your response received via email on March 20, 2017, in which you state your firm has submitted your products to an accredited external laboratory for microbiological testing, and in the past, the tests confirmed the "correct microbiology of canned production." Your response is not adequate because you must update your previously filed scheduled process, or contact a processing authority to complete a new heat penetration study to ensure the effectiveness of this new process.

3.    Your firm did not file evidence in the form of heat distribution data or other suitable information to demonstrate that heat distribution was adequate for the retort installation, as required by 21 CFR 113.40(b)(14). Specifically, the most recent temperature distribution study for your (b)(4) retorts was conducted in June 2006, and the most recent heat penetration study for salmon and tuna salad products in tomato sauce with vegetables was conducted in February 2007. Since then, the (b)(4) retorts have been reconfigured to change the steam supply from direct steam injection into the circulating water inlet pipe to a steam heat exchanger, but no additional temperature distribution and heat penetration studies have been conducted.

We have reviewed your response received via email on March 20, 2017, in which you state your firm will order the testing of the (b)(4) and inform us about the results immediately. You response is not adequate because we have not received any updates from your firm regarding the above-mentioned test results, nor have you submitted any new validation studies as of August 2, 2017.

4.    Your firm did not determine and record the initial temperature of the contents of the containers to be processed with sufficient frequency 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, your firm retains the first can from the (b)(4) retort baskets per batch to determine initial temperature, which is measured as soon as the can is closed instead of immediately before the start of the retort process.

We have reviewed your response received via email on March 20, 2017, in which you provided a document titled, "(b)(4)" which includes instructions (b)(4), and to (b)(4) However, your response is not complete without providing us evidence that your corrections have been completed and implemented.

5.    Your firm's temperature (b)(4) sensor was not located where the recorded temperature was an accurate measurement of the scheduled process temperature, and not affected by the heating media, as required by 21 CFR 113.40(b)(2)(iv). Specifically, the temperature (b)(4) sensors for all (b)(4) retorts are located in the (b)(4) Because of the sensors' location, it measures (b)(4)

We have reviewed your response received via email on March 20, 2017, in which you state your firm's temperature controller-recorder sensor is located in accordance with the design of the retort, and changing its position would result in a structural change to the entire set up. Your response is not adequate because you do not address how you will measure the processing temperatures accurately during the retort step.

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 seafood 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/GuidanceDocumentsRegulatorylnformation/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 that are 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 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 seafood products does not list the food safety hazard of scombrotoxin (histamine) formation associated with your mackerel, herring, and sprat, and undeclared allergens.

We have reviewed your response received via email on March 20, 2017, in which you state the above-mentioned hazard is identified in your firm's document titled, "Risk analysis and preventive action." Although this document identifies histamine as a food safety hazard, your response is not adequate because you did not provide a new or updated HACCP plan that identifies the hazard of scombrotoxin (histamine) formation and includes appropriate critical control points, critical limits, monitoring procedures, recordkeeping, etc., to control the hazard.

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 refu se 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 CMS #532776 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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