- SDP Marketing and Distribution, Inc.
- Issuing Office:
- Los Angeles District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
January 9, 2015 WL #06-15
James D. McKinnon, Owner
SDP Marketing and Distribution, Inc.
1565 Creek St, Suite 101
San Marcos, CA, 92078
Dear Mr. McKinnon:
We inspected your seafood processing facility, located in San Marcos, California, from December 02, 2014 through December 08, 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, 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 dried shrimp and flavored fruit and nut snacksare adulterated, in that they have been 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 received your response letter on December 29, 2014 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
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, your firm does not have a HACCP plan for Dried Whole Shrimp and Dried Jumbo Shrimp that you repack, to control the food safety hazard of undeclared sulfites. The label on the original bulk containers of the products states the products contain added sulfites.
We reviewed your firm’s response and conclude that it is not adequate. Your response included a document identified as a HACCP plan. However, the document does not clearly define the necessary CCPs, critical limits, monitoring procedures, corrective actions, and verification procedures. In addition, you claim to have relabeled the products that lacked the proper sulfite declaration with a sticker until you can obtain new labels. However, no copies of the relabeled items or of the proposed new label were provided. Lastly, you have not provided evidence of training your employees on the new HACCP procedures. Guidance on controlling food intolerance substances and major food allergens can be found in the FDA Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, Chapter 19, Control Strategies 7 & 8.
2. 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 sanitation monitoring records for the safety of the water that comes into contact with food or food contact surfaces; condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage, and use of toxic compounds; control of employee health conditions; and exclusion of pests from the plant, as required for the processing of Dried Shrimp products.
We reviewed your firm’s response and conclude that it is not adequate. Your response states you will maintain these records. However, you have not provided evidence that you are currently maintaining the required records and you have not provided evidence that you have trained the responsible employee(s) on the monitoring and recordkeeping procedures.
Current Good Manufacturing Practices
1. Food contact surfaces are not corrosion resistant and are not designed to withstand the environment of their intended use, withstand the action of food, and withstand cleaning compounds and sanitizing agents, as required by 21 CFR 110.40(a).
Specifically, a (b)(4) brand portable mixer (b)(4) is used for applying flavoring to snack products such as dried mango, pistachios, and roasted peanuts. This cement style mixer is not suitable for food processing as evidenced by the following:
- The three metal blades inside the mixer are missing paint (about 1/5th of the length of each approximately 3" x 24" blade).
- The metal blades have what appears to be an accumulation of rust.
- The metal blades are attached to the plastic drum with bolts that are not welded or otherwise fastened to prevent them from falling into the product.
- The junction between the blades and the barrel is not smoothly bonded to allow adequate cleaning where the blade is attached to the drum.
- The interior surface of the mixing barrel is scratched, discolored, and not easy to clean.
The adequacy of your firm’s response cannot be determined at this time. You state that you have purchased a new food grade mixer, to be delivered by 12/24/14. However, you have not provided evidence of this purchase.
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations.
You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term corrective actions. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
Please send your reply to the Food and Drug Administration, Attention:
CAPT Dan Cline, Acting Director
Los Angeles District
Irvine, CA, 92612-2506
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.
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at (619)-941-3769.
Alonza E. Cruse, Director
Los Angeles District
James D. McKinnon
SDP Marketing and Distribution, Inc
PO Box 2821
Escondido, CA 92033
Harlan Loui, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
Sacramento, California 95899-7413