- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMs. Ana Amezage Meuiudez
Recipient TitleQuality Manager
- Alfonso Garcia Lopez, S.A. - C. Pescamar
Camino Da Fabrica, 3
36995 Poio Pontevedra
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park, MD 20740-3835
OCT, 17 2016
Dear Ms. Amezage:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your low-acid canned seafood processing facility, Alfonso Garcia Lopez, S.A., located at Camino Da Fabrica, 3, Poio, Pontevedra, 36995, Spain on April 4 - 5, 2016. 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 FD A'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 dated April 27, 2016. 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 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 (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 low-acid canned food 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 http://www.fda.gov.
Your significant LACF violations are as follows:
1. Your firm failed to process each low-acid food in conformity with at least the scheduled process as required by 21 CFR 108.35(c)(3) as demonstrated by the following:
a. Specifically, you did not reach the minimum come-up time specified for tuna solid pack in tomato sauce (SID (b)(4)) on April 4, 2016. The come-up time was timed at (b)(4) minutes; however, the minimum filed come-up time filed for this product is (b)(4) minutes. Your response indicated new SID numbers have been assigned however, we did not find a new process filing for tuna solid pack in tomato sauce listed under your firm's FCE (b)(4) in the LACF database. Moreover, this process deviation needs to be evaluated by your process authority to determine whether commercial sterility had been achieved. Filing a new process would not be an adequate course of action, until your process authority had validated the new scheduled process and found it adequate.
b. Specifically, your firm did not reach the minimum initial temperature specified for tuna solid pack in tomato sauce (SID (b)(4)) and for Octopus (SID (b)(4)). On April 4, 2016, the initial temperature for tuna solid pack in tomato sauce was recorded at (b)(4)°C which was lower than the filed initial temperature of (b)(4)°F ((b)(4) °C). And on February 16, 2016, the initial temperature was recorded as (b)(4)°C which was lower than the filed initial temperature of (b)(4)°F ((b)(4)°C). Your response indicated you proceeded to reprocess these products (i.e., repeat the scheduled processes). However your response did not provide production records showing adherence to critical factors specified in the scheduled processes for these products when your firm conducted the re-processing operation. Also your response does not indicate what if any action taken concerning products produced prior to the implementation of this change.
2. Your firm failed to have personnel involved in thermal processing systems under the operating supervision of a person who has attended and successfully completed a school approved by the Commissioner as required by 21 CFR Part 108.35(g). Your response indicated that your Quality Department staff will take part in the Better Process and Control School course in September, 2016.
Seafood HACCP operations:
As a manufacturer of fish and fishery products, failure 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 Act (21 U.S.C. 342(a)(4)). Accordingly, review of your HACCP plan reveals that your 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 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 web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm.
Your significant seafood HACCP violations 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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR Part 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 your frozen and refrigerated tuna (i.e., raw material tuna) does not list the following critical control points for controlling the following food safety hazards that are reasonably likely to occur in your products:
a. Unrefrigerated processing, including thawing of the frozen tuna, trimming, washing, cooking (at least until the last fish from the marked batch is in the cooker and the steam is turned on), cooling, cleaning, filling, oil and sauce addition, sealing, can washing, and thermal processing (until the center of all of the cans from the marked batch achieve 60°C (140°F) during the thermal processing operation) for controlling the food safety hazards of scombrotoxin (histamine) formation, and pathogen growth and toxin formation (i.e., Staphylococcus aureus growth and toxin formation);
b. Refrigerated storage of the raw tuna for controlling the food safety hazard of scombrotoxin (histamine) formation;
c. Cooking (i.e., precooking prior to the start of the canning operation when used to extend the time limit for cumulative time and temperature exposure at ambient temperatures for controlling the food safety hazard of scombrotoxin (histamine) formation.
2. 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 your frozen and refrigerated tuna (i.e., raw material tuna) lists critical limits at the "(b)(4)" critical control point that are not adequate to associated hazards. Specifically,
a. The critical limit "(b)(4)" is not adequate by itself, to control scombrotoxin (histamine) formation during transit for fresh (i.e., not frozen) fish. To ensure that appropriate transportation-handling practices were used throughout transit of your fresh fish, FDA recommends that:
o For fish delivered refrigerated (not frozen):
- All lots received are accompanied by transportation records that show that the fish were held at or below an ambient or internal temperature of 40°F (4.4°C) throughout transit. Note that allowance for routine refrigeration defrost cycles may be necessary;
o For fish delivered under ice:
- Fish are completely surrounded by ice at the time of delivery;
o For fish delivered under ice on an open-bed truck:
- Fish are stored completely surrounded by ice;
- The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;
o For fish delivered under chemical cooling media such as gel packs:
- There is an adequate quantity of cooling media that remain frozen to have maintained product at an internal temperature of 40°F (4.4°C) or below throughout transit;
The internal temperature of the fish at the time of delivery is 40°F (4.4°C) or below;
o For fish delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less (optional control strategy):
- Time of transit does not exceed 4 hours;
- Internal temperature of the fish at the time of delivery does not exceed 40°F (4.4°C).
b. The critical limit "(b)(4)" is not adequate to control pathogen growth and toxin formation, specifically Staphylococcus aureus growth and toxin formation that is reasonably likely to occur in cooked tuna loins during the (b)(4) processing. FDA recommends that if at any time the product is held at ambient temperatures above 70°F (21.1°C), exposure time at ambient temperatures above 50°F (10°C) should be limited to 3 hours when Staphylococcus aureus is the pathogen of concern.
Please note: The critical limit is adequate to control scombrotoxin (histamine) formation during the (b)(4) process.
3. 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 your frozen and refrigerated tuna lists monitoring procedures at the "(b)(4)" critical control point that are not adequate to control scombrotoxin (histamine) formation. Specifically,
a. The monitoring procedure for histamine level indicates the firm will monitor fish flesh for histamine content by "(b)(4)." FDA recommends monitoring the histamine content in the scombrotoxin-forming fish flesh by testing a minimum of 18 fish, collected representatively throughout each lot ( or the entire lot when there are fewer than 18 fish in the lot).
b. The monitoring procedure for time and temperature of exposure during thawing does not ensure conformance with the critical limit for temperature. FDA recommends monitoring the temperature of exposure by measuring ambient air temperature, using:
o A continuous temperature-recording device (e.g., a recording thermometer) located in the processing area with continuous monitoring by the device itself, and a visual check of the device at least once per lot or batch, but no less often than once per day;
o A temperature-indicating device ( e.g., a thermometer) located in the processing area with monitoring at least every 2 hours.
4. 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 firm's corrective action plan for your frozen and refrigerated tuna at the "(b)(4)" critical control point to control scombrotoxin (histamine) formation and pathogen growth and toxin formation is not appropriate. Specifically, the corrective action plan does not correct the cause of the deviation. To correct the cause of the deviation, FDA recommends that firm's discontinue use of the supplier until evidence is obtained that the identified harvesting and onboard practices have been improved. Additionally, the corrective action plan does not ensure that no adulterated product enters commerce and does not ensure that the cause of the deviation is corrected at thawing.
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. 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. In addition, your canned tuna HACCP plan references a sampling plan in the monitoring procedure at the "(b)(4)" critical control point. Please include a copy of this sampling plan in your response to this letter. 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 low-acid canned food 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 low-acid canned food 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: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm2.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the low-acid canned food regulations (21 CFR Parts 108 and 113). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic 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 re-inspection-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. 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 the U. S. Food and Drug Administration, Attention: Donald W. Greaves, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Mr. Greaves at (240) 402-2057 or via email at email@example.com. Please reference 507602 on any submissions and within the subject line of any emails to us.
William A. Correll Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition