- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameTeodoro Martinez
- Martinez Produce & Seafood Inc
340 North Sacramento Boulevard
Chicago, IL 60612
- Issuing Office:
- Office of Human and Animal Food Operations East Division VI
April 28, 2021
Dear Mr. Martinez,
The United States Food and Drug Administration (FDA) inspected your seafood processing facility and importer establishment, Martinez Produce & Seafood Inc., located at 340 North Sacramento Boulevard, Chicago IL, 60612 on January 5, 2021 through January 14, 2021. During our inspection, we found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).
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). Based on our inspectional results, your imported, refrigerated fin fish, including but not limited to tuna, mackeral, flounder fish and salmon, are 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), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
At the conclusion of the inspection, the FDA investigators issued you a Form FDA 483, Inspectional Observations, listing the observations made at your firm. We received your written response on Febuary 17, 2021, which contains a letter and a few attached documents. We have reviewed the documentation and continue to have serious concerns with your current HACCP programs as further described in this letter.
Your significant deviations are 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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). However, you do not have a HACCP Plan for fresh tuna and salmon in reduced oxygen packaging to control the hazard of Clostridium botulinum growth and toxin formation, distributed direct to consumers directly through online sales. Specifically, our investigators observed the processing of small portions of tuna which were vacuum packed in reduced oxygen packaging (ROP) for distribution. When asked if your firm had a HACCP plan for ROP processed seafood, your employee stated your firm did not currently have a HACCP plan for ROP fin fish.
We have reviewed your corrective action of discontinuing the practice of vaccum packaging your fresh seafood, including fresh tuna and salmon products. In your response, you state that you now use (b)(4) freezer bags to package your fresh seafood. If implemented correctly, this corrective action should be sufficient to address the hazard of Clostridium botulinum growth and toxin formation. We will assess the adequacy of this corrective action during our next inspection.
2. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm does not have nor has implemented an affirmative step for Tuna (imported from (b)(4)), mackerel (imported from (b)(4)), and Flounder fish (imported from (b)(4)). Specifically, when our investigators asked to review your affirmative step documents, your employee stated you did not currently have an import verification program. In addition, the same employee stated you were unfamiliar with your suppliers’ operations and do not have any information for the control of hazards in the seafood products imported from your suppliers.
We have reviewed your corrective action which included the creation of a " a “Foreign Supplier HACCP USA-FDA Compliance Form”, requesting suppliers to provide the date of their last FDA inspection, certification that they are following GMPs, and SSOPs per 21 CFR Part 110, as well as, their most current “USA-Compliant” HACCP plan. For your awareness, 21 CFR Part 110 is now obsolete. As of September 17, 2018, all food manufacturers are subject to 21 CFR Part 117, Subparts A and B, the General Provisions and the modernized GMPs, respectively. Seafood facilities are required to follow the seafood HACCP regulations under 21 CFR Part 123 and the CGMPs regulations under 21 CFR Part 117, Subpart B. We acknowledge you provided a blank “Foreign Supplier Verification Program” form and a completed “Foreign Supplier Verification Program” form dated January 27, 2021. Furthermore, although you stated you have requested your supplier’s HACCP plan and a statement that the imported fish or fishery product is processed in accordance with the requirements of HACCP and FSMA, you did not provide these records for each of your foreign suppliers. We will verify the adequacy of your corrective action during our next inspection.
3. Your must monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs), that are appropriate to your plant and the food being processed and related to one of the areas specified in 21 CFR 123.11(b)(1)—(8), to comply with 21 CFR 123.11(b). However, you did not monitor the following conditions and practices with sufficient frequency to ensure compliance with 21 CFR 117, Subpart B (CGMPs):
a) You did not monitor conditions and practices with sufficient frequency to ensure that you clean and sanitize your utensils or equipment in a manner that protects against contamination, as required by 21 CFR 117.35(a) and 21 CFR 123.11(b)(2). Specifically, our investigators observed your cleaning and sanitization of knives used to cut ready-to-eat blue fin tuna. Your employee dipped the knives in a (b)(4) solution, wiped the solution off, and then placed the knives into a smaller grey plastic container filled with a (b)(4) solution. Once placed in the grey plastic container, the knives are considered ready for use. No detergent was used during cleaning. Visible residual food debris was observed on the knives after your cleaning and sanitizing activities.
b) You did not monitor conditions and practices with sufficient frequency to ensure that effective measures are taken to protect finished food from contamination, as required by 21 CFR 117.80(c)(6) and 21 CFR 123.11(b)(3). Specifically, our investigators observed cleaning operations in the refrigerated processing room where whole, ready-to-eat blue fin tuna and open boxes of ready-to-eat salmon were stored. Multiple employees were observed using high-pressure hoses to remove debris from food contact surfaces, the floor, and the floor drains adjacent to the ready-to-eat tuna and salmon.
Your response includes descriptions of the corrective actions that you have taken, such as, educating your employees in the principles and procedures related to cleaning and sanitization of utensils. You also state that you have corrected your SSOP recording forms to included monitoring of sanitizating for contact surfaces and their frequency. You provided a blank “Sanitation Condition” form. However, you did not provide any documentation, such as training records, utilized sanitation forms, photographs of the cleaned knives, and cleaning and sanitization procedures to include a cleaning step for utensils. Futhermore, FDA recommends avoiding the use of high-pressure water hoses during production in areas where RTE foods are exposed or after equipment has been cleaned and sanitized. In addition, we recommend that you monitor conditions with sufficient frequency to ensure employee practices prevent cross-contamination. We will verify the adequacy of these corrective actions during our next inspection.
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 including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. More specifically, your response should include documentation reflecting the changes you made, such as a copy of your revised HACCP plan or plans, written verification procedures, product specifications, and an affirmative step for fish you import. You should also provide five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of 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 seafood HACCP regulation. 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 your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
You should take prompt action to address the matters cited in this letter. Failure to adequately address may lead to regulatory action without further notice including, without limitation, seizure and injunction. Additionally, 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 importer establishments that are not in compliance with the seafood HACCP regulation is Import Alert # 16-119, Detention Without Physical Examination of Fish and Fishery Products for Importer and Foreign Processor (Manuf) Combinations. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
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 seafood HACCP regulation and the Current Good Manufacturing Practice regulation (21 CFR 117 Subpart B). 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 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 reinspection fees (21 U.S.C. 379j-31(a)(2)(B)).
Please send your reply to the Food and Drug Administration, Attention: Lauren Crivellone, Compliance Officer, 550 W. Jackson Blvd, Chicago, IL 60661. If you have questions regarding any issues in this letter, please contact Ms. Crivellone at (312) 595-4157 or by email at Lauren.Crivellone@fda.hhs.gov.
Program Division Director
Office of Human and Animal Food
Operations East Division VI