- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Food & Beverages
Recipient NameMr. Alex C. Lee
Recipient TitleVice President
- MT Trading Corp
1411 Hutchins St.
Houston, TX 77003
- Issuing Office:
- Division of Southwest Imports
June 5, 2017
Dear: Mr. Alex Lee,
The U.S. Food and Drug Administration (FDA) inspected your seafood importer facility, located at 1411 Hutchins St, Houston, TX on 3/27/2017 and 4/7/2017. We found that you have 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). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer offish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12( d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123.
If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), and will be denied entry.
Because our inspection identified serious violations for 21 CFR Part 123, your Dried Herring and Dried Anchovy are adulterated under 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 may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's homepage at www.fda.gov.
Your significant violations were as follows:
1. You do not have or have not provided evidence that the fishery products you import have been processed under conditions that comply with the Seafood HACCP regulation. This violation was noted during previous inspections of 2005, 2009 and 2015.
Specifically, the product specification record of Dried Herring does not list or address the significant hazards of histamine and parasites. The Foreign processor HACCP plan for Dried Herring list all significant hazard including histamines and parasites. Since ·your product specifications record is incomplete, your firm does not have any records or procedures in place to ensure you received products within the acceptance levels of those hazards, as required by 21 CFR 123.12(d).
2. You do not have or have not implemented written verification procedures for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation. The written verification procedures shall list, at minimum: (1) product specifications designed to ensure that the product is not adulterated under the Act because it may be injurious to health or have been processed under insanitary conditions; and (2) affirmative steps, as required by 21 CFR 123.12(a)(2).
Specifically, your firm did not implemented your written verification procedures which list obtaining a continue certificate as the affirmative step for the imported Dried Anchovy products. At the time of inspection, your firm did not have any continuing certificate verification records available for review for this product, as required by 21 CFR 123.12(c).
3. You have failed to maintain records that document the performance and results of affirmative steps, as required by 21 CFR 123.12(c) and 123.9.
Specifically, the written verification procedures record affiliated to Dried Anchovy list continuing certificate as an affirmative step. Your firm does not have any records to demonstrate the steps was properly implemented in accordance to HACCP regulations.
Your firm does not have product specification record for the imported Dried Anchovy product. The firm is utilizing the foreign processor's product specification record as means to address the significant hazard associated with Dried Anchovy, as required by 21 CFR 123.12.
4. Your records do not include the name and locations of the processor or importer, date and time of the activity the record reflects and signature or initials of the person performing the operation, as required by 21 CFR 123.9 (a).
The product specification record for the imported Dried Herring did not contain a signature by firm employee nor date the record was implemented at the firm.
We may take further action if you do not promptly correct these violations. 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," seize your product(s), and/or enjoin your firm from further violating the Act.
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 HACCP and importer verification records and records that document the performance and results of your firm's affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Your written response should be sent to Rosa Linda Santos, Compliance Officer, U.S. Food and Drug Administration, North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about this letter, please contact Compliance Officer Rosa Linda Santos at (214) 253-5269 or by e-mail at email@example.com.
Division of Southwest Imports