Inspections, Compliance, Enforcement, and Criminal Investigations
Woolery Enterprises, Inc., Dba Will's Fresh Foods 6/1/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
431 Harbor Bay Parkway
Alameda. CA 94501-7070
Telephone: (510) 337-6700
VIA UNITED PARCEL SERVICE
Our Reference: FEI 3004327171
June 1, 2012
Daniel C. Woolery, President
Woolery Enterprises, Inc.
Dba Will's Fresh Foods
1991 Republic A venue
San Leandro, California 94577
Dear Mr. Woolery:
We inspected your seafood processing facility, Woolery Enterprises, Inc. doing business as Will's Fresh Foods, located at 1991 Republic Avenue, San Leandro, California, on April 25, 26, 27 and May 8, 2012. 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 refrigerated, ready-to-eat tuna salad and refrigerated, ready-to-eat seafood salad 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 are as follows:
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 have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for "Temperature abuse of Seafood Salad" does not list the food safety hazard of histamine formation in your refrigerated, ready-to-eat tuna salad, as a result of time/temperature abuse specifically during the cooler storage of the finished tuna salad product. During the inspection, your Quality Assurance Manager told our investigator that your "Temperature abuse of Seafood Salad" HACCP plan is used for all seafood including the ready-to-eat tuna salads.
2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for "Temperature abuse of Seafood Salad" does not list the following critical control points:
a) Seafood Cooler Storage (during the Thawing Step) to control pathogen growth and toxin formation;
b) Metal Detector to control metal inclusion;
c) Finished Product Labeling to control allergens; and
d) Refrigerated Storage to control histamine formation in your tuna salads, and pathogen growth and toxin formation in all your seafood salads.
To establish the appropriate critical limits, monitoring procedures, corrective actions, verification, and record-keeping system, please refer to the 4th Edition of the HACCP Guide.
3. 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) 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 "Temperature abuse of Seafood Salad" lists a critical limit (b)(4) critical control point that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin in the surimi seafood salad. Your HACCP plan does not identify which specific parameter is to be controlled, i.e., the product internal temperature or processing room temperature.
4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for "Temperature abuse of Seafood Salad" lists a monitoring procedure of (b)(4) critical control point that is not adequate to control pathogen growth and toxin formation including Clostridium botulinum toxin in the surimi seafood salad. Your HACCP plan does not identify what temperature is to be monitored, i.e., the product internal temperature or processing room temperature.
5. 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 our corrective action plan for "Temperature abuse of Seafood Salad" at the (b)(4) critical control point to control pathogen growth and toxin formation including Clostridium botulinum toxin in surimi seafood salad is not appropriate. When a critical limit deviation occurs, FDA recommends not only addressing the product involved but also addressing the process. ln this instance, in addition to lowering the temperature of the affected product, FDA recommends modifying the process as needed to reduce the time and temperature exposure.
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 of 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Lawton W. Lum, Director of Compliance, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070. If you have questions regarding any issues in this letter, please contact Compliance Officer Erlinda Figueroa at (510) 337-6795.
Barbara J. Cassens
San Francisco District