MAY 3, 2018
VIA EXPRESS DELIVERY
Mr. Paulo Vaz Machado
Ramirez & Ca. (Filhos)
Rua do Passadouro, 135, P.O. Box 2050
Matosinhos, Porto, 4451-953 Portugal
Reference # 547978
Dear Mr. Paulo Vaz Machado:
On December 7-8, 2017, a representative of the United States Food and Drug Administration (FDA) inspected your seafood processing facility, Ramirez & Ca. (Filhos) S.A. located at Rua do Passadourno no. 135, Matosinhos, Porto, Portugal. That inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). That inspection resulted in FDA’s issuance of an FDA 483, Inspectional Observations that lists the serious deviations found at your firm.
Your firm responded to the FDA 483 via email on December 27, 2017, stating that your HACCP plan is “under revision” and “will be completed end of first 2018 quarter.” Subsequently, at the request of FDA, your firm submitted a revised HACCP plan on February 23, 2018, entitled “HACCP Plans Sardines in different sauces.” We have evaluated that revised HACCP plan and found that you have continuing serious deviations of the seafood HACCP regulation, as further explained 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 sardines packed in different sauces are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
We found the following significant deviations:
1. 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 revised HACCP plan provided with your February 23, 2018, email for canned sardines packed in different sauces lists the following critical limits that are not adequate to control scombrotoxin (histamine) formation. Specifically:
a. At the “(b)(4)” critical control point, the critical limits of “(b)(4)” are not adequate to control scombrotoxin (histamine) formation that is reasonably likely to occur onboard the harvest vessel. Your firm is a primary processor receiving the fish directly from the harvest vessels. Consequently, your firm needs to ensure control of scombrotoxin (histamine) formation that is reasonably likely to occur while the sardines are onboard the harvest vessel. FDA recommends for control of scombrotoxin (histamine) formation related to handling practices onboard the harvest vessel, that firms include histamine analysis (i.e., for firms such as yours using the histamine testing strategy) on a representative sample of scombrotoxin forming fish that shows less than 50 ppm histamine in all fish in the sample. In addition, all primary processors need to include sensory examination of a representative sample of scombrotoxin forming fish that shows decomposition (persistent and readily perceptible) in less than 2.5% of the fish in the sample. For example, no more than (b)(4) fish in a sample of (b)(4) fish may show signs of decomposition. In addition, all primary processors need to ensure that the fish were held under proper refrigerated temperatures or under adequate ice while in storage onboard the vessels by taking internal temperatures of the fish at the time they are off-loaded from the vessels. For the fish that are frozen onboard the harvest vessel, internal temperature monitoring at the time of off-loaded is not necessary.
Lastly, your firm is not located at the wharf where the sardines are off-loaded from the harvest vessel, and consequently the sardines are in transit prior to receipt. FDA recommends for control of scombrotoxin (histamine) formation during transit to the facility from the wharf, that firms ensure the products were maintained under proper refrigerated temperatures or that the products were completely surrounded by ice for the duration of the transit period.
b. At the “(b)(4)” critical control point, the critical limits of “(b)(4)” are not adequate to control scombrotoxin (histamine) formation during extended holding/storage times. Your listed temperature of (b)(4)˚C is higher than the recommended temperature of 4.4 °C, necessary to prevent time and temperature abuse. Additionally, histamine testing is not recommended at the storage critical control point. FDA recommends that firms either use equipment capable of continuously monitoring and recording the cooler temperatures during the storage period; or that firms ensure that products are completely and continuously surrounded by ice during the entire storage period.
c. At the “(b)(4)” critical control point, the critical limits of (b)(4)” are not adequate to control scombrotoxin (histamine) formation. FDA recommends that during processing (e.g., butchering, cleaning, brining, cutting , filling, steaming, staging, packing, etc. ) of scombrotoxin forming fish that have not been previously frozen, the fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 4 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C). During processing (e.g., thawing, butchering, cleaning, brining, cutting, filling steaming, staging, packing, etc.) of scombrotoxin forming fish that have been previously frozen, that the fish are not exposed to ambient temperatures above 40°F (4.4°C) for more than 12 hours, cumulatively, if any portion of that time is at temperatures above 70°F (21.1°C);
For additional information related to control of scombrotoxin (histamine) formation, please refer to Chapter 7 of the Hazards Guide, which includes specific information related to primary and secondary processor receiving controls (including transit controls), unrefrigerated processing controls, and refrigerated storage controls at: https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM252400.pdf
Please be advised that once you have amended your HACCP plan to include adequate critical limits at each of the critical control points, your firm needs to ensure that you also include adequate corresponding monitoring procedures, recordkeeping, and corrective actions (i.e., should your firm choose to include corrective actions in your plan). Corrective actions must address both the disposition of the affected products and address the correcting the cause of the deviation.
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 monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the applicable laws and regulations. Submission of the information in English will assist in our review. 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 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 fish or fishery 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 seafood HACCP regulation is Import Alert #16-120. You may view this alert at
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 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.
Please send your reply to Food and Drug Administration, Attention: Philip Bermel, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Mr. Bermel via email at Philip.Bermel@fda.hhs.gov. Please reference CMS# 547978 on any submissions and within the subject line of any emails to us.
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition