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WARNING LETTER

100Misterios, LDA MARCS-CMS 688258 —

Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Adriano Ribeiro
Recipient Title
Owner
100Misterios, LDA

Armazem C
Rua Do Progresso 145 matosinhos
4455-533 Perafita, Porto
Portugal

adriano.ribeiro@josegourmet.com
Issuing Office:
Center for Food Safety and Applied Nutrition

United States

WARNING LETTER

Reference # 688258

Dear Mr. Adriano Ribeiro:

The U.S. Food and Drug Administration (FDA) inspected your low-acid and seafood manufacturing facility, 100Misterios, LDA, located at Armazem C, Rua Do Progresso 145matosinhos, Perafita, Porto, Portugal 4455-533 from April 3-5, 2024. During that inspection, we found that you had serious deviations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR 123), the Emergency Permit Control regulation (21 CFR 108), and the Thermally Processed Low-Acid Foods (LACF) Packaged in Hermetically Sealed Containers regulation (21 CFR 113). At the conclusion of the inspection, an FDA-483, Inspectional Observations, was issued listing the serious deviations found at your firm. We acknowledge receipt of your response via email on April 26, 2024, which included corrective actions taken in response to the FDA-483, as well as a revised HACCP plan. However, our evaluation of the documentation provided in your responses revealed that your response was not adequate, as further described in this letter.

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section 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 sardine packed in olive oil 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 Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.

As a manufacturer of LACF food products intended for export to the United States, you are required to comply with the Federal Food Drug and Cosmetic Act (the Act) and the Federal regulations relating to the processing of LACF foods. As outlined in the regulations, a commercial processor of LACF foods 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, for imported products, in lieu of issuing an order of determination that a permit is required before products from such 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. Violations of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR 113 renders your LACF products adulterated within the meaning of section 402(a)(4) of 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 rendered injurious to health. You can find the Act and the LACF regulations through links in FDA's home page at www.fda.gov.

Your significant violations are as follows:

Seafood HACCP Violations (21 CFR 123)

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 multiple seafood products (e.g., for mackerel, sardine, trout, and tuna) does not list the food safety hazards of Staphylococcus aureus growth and toxin formation and undeclared major food allergens.

2. 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm’s HACCP plan for Mackerel (Scomber scombrus), Sardine (Sardina pilchardus), and tuna (Thunnus albacores, Katsuonus pelamis) does not list critical control points at the (b)(4) processing steps to control the hazards of histamine (scombrotoxin) formation, pathogenic bacteria growth – temperature abuse and toxin formation (e.g., S. aureus), and undeclared food allergens.

3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for Mackerel (Scomber scombrus), Sardine (Sardina pilchardus), and tuna (Thunnus albacores, Katsuonus pelamis), lists “Sensory examination ((b)(4)% show decomposition)” as a critical limit at the (b)(4) critical control point (CCP1) that is not adequate to control histamine. Specifically, the Sensory Examination Critical Limit does not specify that at least (b)(4) fish should be examined. The (b)(4) fish should be collected representatively throughout each lot (or the entire lot, for lots smaller than (b)(4) fish).

4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm’s HACCP plan for Sardines (Sardine pilchardus) lists a monitoring procedure at the (b)(4) critical control point that is not adequate to control the identified hazard of histamine. Specifically, your HACCP lists a monitoring procedure of “(b)(4)” under “(b)(4).” This procedure is insufficient in explaining the (b)(4) procedures and does not ensure compliance with the critical limit at your (b)(4) CCP1.

5. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for multiple seafood products (e.g., for mackerel, sardine, trout, and tuna) and processes at the “(b)(4)” critical control point to control for the hazard of “(b)(4)” is not appropriate. Specifically, your corrective action procedure of “(b)(4)” does not ensure that the affected products do not enter into interstate commerce, and that the cause of the deviation is corrected. When you list corrective action procedures in your HACCP plan, those procedures must ensure that whenever a deviation from a critical limit occurs the corrective action prevents potentially unsafe seafood from entering commerce and that the source or cause of the deviation is addressed to prevent a reoccurrence of the deviation, as required by 21 CFR 123.7(c)(3) and (c)(4).

LACF Foods Violations (21 CFR 113)

6. As a commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers, you must process each low-acid food in each container size in conformity with at least the scheduled process, as required by 21 CFR 108.35 (c)(3)(i). Specifically, our investigator reviewed your scheduled process filed with the FDA for your (b)(4) oz. canned sardines in extra virgin olive oil. The (b)(4) penetration study, as submitted with your scheduled process, identifies jumble loading of approximately (b)(4) containers (cans) per basket. You are not processing your canned sardines in extra virgin olive oil in accordance with your scheduled process, as described below:

a. On 4/4/2024, our investigator observed the retort basket be filled with approximately (b)(4) cans, on December 16, 2022, Lot (b)(4) was retorted with (b)(4) cans, and on January 1, 2023, Lot (b)(4) was retorted with (b)(4) cans.

b. On 4/4/2024, our Investigator observed lemon slices were hand-packed into cans with product prior to sealing and retort.

In your response, you provide supporting documentation from your process authority identifying the maximum capacity of baskets to be equal to or greater than, (b)(4) cans per retort. You also provide a (b)(4) penetration study including the use of lemon within your canned sardines packed in olive oil product. However, as required by 21 CFR 108.35(c)(2)(ii), if a packer intentionally makes a change in a previously filed scheduled process by reducing the initial temperature or retort temperature, reducing the time of processing, or changing the product formulation, the container, or any other condition basic to the adequacy of scheduled process, he shall prior to using such changed process obtain substantiation by qualified scientific authority as to its adequacy and notify the agency accordingly. To date, we have not received any new filings with the FDA for your canned sardines in olive oil products, or any requests to change your currently filed scheduled processes.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, including processing records for five lots of product produced over at least five days. 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 believe that the foods you import are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

If you do not respond, or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported LACF and seafood 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, examples of Import Alerts that conveys information specific to foreign firms that are not in compliance with the LACF and seafood HACCP food regulations (21 CFR 108, 113, and 123), are Import Alert #99-38, “Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods Due to Inadequate Process Controls” and Import Alert #16-120, "Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP". These alerts can be found on FDA's web site at https://www. accessdata.fda.gov/cms_ia/importalert_1132.html and https://www.accessdata.fda.gov/_ia/importalert_25.html.

In addition to the above, we also offer the following comments:

  • Your revised HACCP plan, as provided in your response, groups multiple types of fish and fishery products (e.g., mackerel, sardines, trout, tuna), which contain differing food safety hazards, such as different species related hazards. As required by 21 CFR 123.6 (a), and (b)(2), 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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur. A plan may group multiple fishery products that have identical food safety hazards, production methods, and HACCP plan controls. Additionally, it appears your products of canned smoked salmon in extra virgin olive oil, canned garfish in extra virgin olive oil, canned cuttlefish in ink with shrimp pâté, and canned smoked salmon pâté products have been omitted from your HACCP plans. FDA recommends listing all pertinent products processed at your facility, and grouping multiple fish and fishery products that have identical food safety hazards, production methods, and HACCP plan controls.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Emergency Permit Control regulation (21 CFR 108), the LACF Foods regulation (21 CFR 113), the Seafood HACCP regulation (21 CFR 123), and the current Good Manufacturing Practice regulation (21 CFR 117).

Please send your reply to the Food and Drug Administration, Attention: Amy R. Glynn, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A., or send via email at amy.glynn@fda.hhs.gov. Please reference CMS # 688258 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition

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