Inspections, Compliance, Enforcement, and Criminal Investigations
P & D Seafood Company Inc 3/26/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
March 26, 2014
Ching H. Wang, President / Owner
P & D Seafood Company Inc.
920 Agatha Street
Los Angeles, CA 90021
Dear Mr. Wang:
We inspected your seafood processing facility, located at 920 Agatha Street, Los Angeles, California from September 25 through September 27, 2013.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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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 fish and fishery products such as your canned raw scallops and canned pasteurized crab meat are adulterated, in that they havebeen prepared, packed, or held under insanitary conditions whereby theymay 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.
We acknowledge receipt of your written response dated October 18, 2013. We have reviewed your response, which included an updated HACCP plan, as well as corresponding records. However, based on your response and your HACCP plan that was provided, your canned raw scallops and canned pasteurized crab meat continue to be adulterated. The significant violations are 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." However, your firm’s HACCP plan for “Canned Raw Scallops” lists a critical limit, (b)(4), at the (b)(4) critical control point that is not adequate to control the hazard of “Chemical” [Clostridium botulinum toxin formation]. FDA recommends that when transit times are extensive (i.e., greater than 4 hours) that firms ensure that temperatures are continuously maintained at or below 38°F for the entire duration of the transit period. This is particularly critical because products such as your raw scallops packed in cans contain no secondary barrier (In addition to refrigeration) to control toxin formation by C.botulinum type E and non-proteolytic types B and F during finished product storage and distribution. These types of C.botulinum will grow at temperatures as low as 38°F, necessitating particularly stringent control. Your canned raw scallops are (b)(4) from your supplier located in (b)(4) to Los Angeles, California. However, the scallops are not accompanied by transportation records or another adequate means to ensure that the product was held at or below 38°F throughout transit. In addition, this product contains no barriers (other than refrigeration) to toxin formation by C.botulinum type E and non-proteolytic types B and F during finished product storage and distribution. These types of C.botulinum will grow at temperatures as low as 38°F, necessitating particularly stringent control. Maintenance of temperatures below 38°F after the product leaves your control and enters the distribution system cannot normally be ensured. The use of a TTI (time temperature indicator) on the smallest unit of packaging, may be an appropriate means of overcoming these problems in the distribution system. Please refer to Chapter 13 of the Fish and Fishery Products hazards and Controls Guidance, 4th Edition.
2. 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,
a. your corrective action plan for “Canned Raw Scallops” at the (b)(4) critical control point to control “chemical” [Clostridium botulinum toxin formation] is not appropriate because it does not address the steps to be taken to ensure that the cause of the deviation is addressed (i.e., discontinue use of supplier until evidence is obtained that transportation-handling practices have been improved).
b. your corrective action plan for “Canned Pasteurized Crabmeat” at the (b)(4) critical control point to control “chemical” [Clostridium botulinum toxin formation] is not appropriate because it does not address the steps to be taken to ensure that the cause of the deviation is addressed (i.e., discontinue use of supplier until evidence is obtained that transportation-handling practices have been improved).
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) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Your firm’s response should be sent to:
Mr. Blake Bevill, Director
United States Food and Drug Administration
Irvine, CA 92612-2506
If you have questions regarding this letter, please contact Marco Esteves, Compliance Officer, at 949-608-4439.
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 reinspection-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. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
- Your corrective action plan for “Scombroid Fish” at the (b)(4) critical control point to control the hazard of “Chemical Scombrotoxin formation” lists a corrective action of (b)(4). However, you should evaluate the pertinent hazard (histamine formation).
- Your “Canned Raw Scallops” and “Canned Pasteurized Crabmeat” plans list the hazard of “Chemical”, which is referred to in your hazard analysis as “Toxin formed when temperature abused”. However, your plan should specify the hazard of Clostridium botulinum growth and toxin formation.
- Imported Products
- Product specifications should ensure that the product is not adulterated under section 402 of the Act. However, the specifications you provided with your response do not include any potential safety hazards (i.e., water activity, pH, histamine formation, pathogen limits, aquaculture drugs, parasites etc.). Please refer to Chapter 2 and 3 of the Fish and Fishery Products hazards and Controls Guidance, 4th Edition.
Alonza E. Cruse
Los Angeles District