Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive
Baltimore, MD 21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705
RETURN RECEIPT REQUESTED
March 6, 2014
Mr. Timothy Harris, CEO
La Tienda, Inc.
3601 La Grange Pkwy, #200
Toano, VA 23168
Dear Mr. Harris:
On behalf of the US Food and Drug Administration, the Virginia Department of Agriculture & Consumer Services (VDACS) inspected your seafood warehouse located at 3601 La Grange Pkwy, #200, Toano, VA 23168, on November 20, 2013. During the inspection your firm was found to have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, (21 CFR 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).
Accordingly, your Mojama Dry-Cured Tuna Filets; Nardin Anchovy Filets (unsmoked variety); and Cantabrian Anchovy Filets are adulterated, 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 home page at www.fda.gov.
Your significant violations were as follows:
- You did not conduct and document a hazard analysis for Mojama Dry-Cured Tuna Filet. 21 CFR 123.6 (a)
- You do not have a written HACCP plan for Mojama Dry-Cured Tuna Filet. 21CFR 123.6 (b)
- Your HACCP plan for Nardin Anchovy Filet does not identify Clostridium Botulinum and bacterial growth as significant hazards. 21 CFR 123.16(c)(2)
- There are no records to document that corrective actions were taken according to the HACCP plan for the Nardin Anchovy Filet when the temperature critical limit value of 40°F for the walk in cooler was surpassed. 21 CFR 123.7(d)
- Monitoring of sanitation conditions and practices in required areas are not done with sufficient frequency to assure conformance to cGMPs. 21 CFR 123.11(b)
Several of the above observations are repeated violations from the previous VDACS August 7, 2013 inspection.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating. 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. In your response you should include documentation such as HACCP and verification records, 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 processing plant 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.
Please send your reply to the Food and Drug Administration, Attention: Ms. Evelyn Bonnin, District Director. If you have questions regarding any issues in this letter, please contact Compliance Officer, CDR Rochelle B. Young, RPh, MSA at 410-779-5437.
Baltimore District Director
Pamela W. Miles, Program Supervisor
102 Governor Street. 3rd Floor
Richmond, VA 23219