- Lao Thai Nam Corporation
- Issuing Office:
- Dallas District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
July 24, 2014
Koui Phaxay, Owner
Lao Thai Nam Corporation
4444 W. Illinois Ave., Suite 400A
Dallas, TX 75211
Dear Mr. Phaxay:
We inspected your seafood processing facility Lao Thai Nam Corporation, located at 4444 W. Illinois Ave, Suite, 400A, Dallas, Texas 75211 on March 24, 2014 through April 4, 2014. 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 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 Number One Sompa Salted Fish is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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, Fourth Edition (HACCP Guide) through links in FDA's home page at www.fda.gov
Your significant violations were as follows:
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."
a. Your firm’s HACCP plan for Salted Fish lists a critical limit at the (b)(4) critical control point (CCP) that is not adequate to control the hazard of pathogen growth and toxin formation. Specifically, the critical limit of “(b)(4)” is not adequate to control pathogen growth and toxin formation during your (b)(4) process. A (b)(4) of (b)(4) does not control the growth of Bacillus cereus or the growth and toxin formation of Staphylococcus aureus.
In addition, it appears there are no controls in place in your process to prevent pathogen growth and toxin formation.
Further, we note your revised draft HACCP plan provided during the inspection does not include a (b)(4) CCP and does not list any secondary barriers for Clostridium botulinum toxin production. As the finished product is frozen, it is appropriate to have a CCP for labeling to ensure the labels state to keep the product frozen.
We suggest your firm conduct or have conducted a hazard analysis to determine what food safety hazards are reasonably likely to occur for your fishery products.
For more information on critical limits associated with Clostridium botulinum, see Chapter 13 of the HACCP Guide. For more information on critical limits associated with pathogens see Chapter 12 of the HACCP Guide.
b. Your firm’s HACCP plan for Salted Fish lists a critical limit at the Cold Storage of raw ingredients CCP that is not adequate to control Clostridium botulinum. Specifically, the critical limit of “Storage Temperatures to be kept ≤ (b)(4)°F”, is not sufficient to control Clostridium botulinum in your uneviscerated, unprocessed, vacuumed-packed, frozen fish ingredients. Our inspection found your firm receives uneviscerated, unprocessed, vacuum-packed, frozen fish which are sometimes stored in your firm’s cooler. The critical limit of (b)(4)°F does not control toxin formation by Clostridium botulinumtypes E, B, and F.
Further, we note your revised draft HACCP plan provided during the inspection does not provide for a secondary barrier for Clostridium botulinum and therefore the critical limits should be less than or equal to 38°F, or require the product be frozen. Also, the revised draft HACCP plan lists a monitoring procedure at your “Cold Storage of raw ingredients” CCP that identifies you will monitor the (b)(4) temperature monitoring device every (b)(4). This does not provide for continuous monitoring of the temperature, which is necessary to control the hazards of Clostridium botulinum.
c. Your firm’s HACCP plan for Salted Fish lists a critical limit at the Cooling (b)(4) CCP that is not adequate to control the hazards of pathogen growth and toxin formation. Specifically, the critical limit of “During cooling the product’s internal temperature is reduced from final (b)(4) degrees in no more than (b)(4) and then from (b)(4) degrees to (b)(4) degrees in (b)(4)” is not adequate to control the hazards of pathogen growth and toxin formation.
2. In addition, you must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm does not maintain records showing you are monitoring the eight key areas of sanitation identified in 21 CFR 123.11(b).
We acknowledge your firm provided a draft HACCP plan during the inspection; however, this HACCP plan is also deficient if implemented for the processes observed during the inspection. Specifically, the critical limit for the “(b)(4)” is inadequate to control the hazard of Clostridium botulinum, as discussed above. Further, the verification procedures for the “(b)(4)” and “(b)(4)” critical control points are deficient because they do not include requirements for daily accuracy checks of the temperature monitoring devices.
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. You should include in your response 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, 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.
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 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 domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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 send your reply to the Food and Drug Administration, Attention: Jeff R. Wooley, Compliance Officer, 4040 N. Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Jeff R. Wooley, Compliance Officer at 214-253-5251.
Reynaldo R. Rodriguez
Dallas District Director