Inspections, Compliance, Enforcement, and Criminal Investigations
Pacific Pre-Cut Produce, Inc. 16-Mar-05
Department of Health and Human Services
Public Health Service
San Francisco District
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Our Reference: FEl 1000449658
March 16, 2005
Steffanie C. Smith, President
Pacific Pre-Cut Produce, Inc.
100 W. Valpico Road, Ste A
Tracy, California 95376-8198
Dear Ms. Smith:
On October 26 to November 3, 2004, we inspected your seafood processing facility located at 100 W. Valpico Road, Suite A, Tracy, California . We found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (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 to have and implement a HACCP plan that complies with this section, or otherwise operate in accordance with the requirements of this part, renders the 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, pasteurized, vacuum packaged imitation crabmeat, refrigerated ceviche, and refrigerated seafood salad dressing containing surimi and/or cooked shrimps that are packed into seafood salad kits are adulterated, in that the fishery products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health . You may find the Act, the seafood HACCP regulation, and the Food and Drug Administration's (FDA) Fish & Fisheries Products Hazards & Controls Guidance, 3rd edition, June 2001 through links in FDA's home page at www.fda. gov
The most serious deviations were as follows:
1. 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 "Cooked Seafood" does not list':.
(a) Receiving and Storage critical control points for the refrigerated cevicbe product containing cooked shrimp and the refrigerated seafood salad dressing containing surimi;
(b) A Thawing critical control point of the IQF cooked ready-to-eat shrimp that is used in the salad kits; and
(c) A Storage critical control point of the refrigerated seafood salad dressing and seafood salad kits.
2. 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 Part 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 plans for "Pasteurized Seafood" lists a critical limit of [redacted] F" at the Receiving critical control point that is not adequate to control pathogens including C. botulinum toxin formation in refrigerated, vacuum packaged pasteurized surimi seafood product (i.e., imitation crabmeat).
For fishery products transported longer than four (4) hours, your HACCP plans should include, at the Receiving critical control point, a critical limit to assure that safe temperatures were maintained throughout transportation. FDA recommends either checking the adequacy of cooling media at the time of delivery or requiring that all lots be accompanied by records that show continuous monitoring in the truck to ensure temperatures were at or below 40°F throughout transport.
3. Since you chose to include corrective actions in your HACCP plans, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for:
(a) Refrigerated, pasteurized imitation crabmeat products (surimi seafood product) at the Product Storage, Packaging, and Storage critical control points are not appropriate to determine product safety concerning C. botulinum toxin formation, and
(b) Refrigerated, cooked shrimp, seafood dressing for pasta salads, and ceviche product containing cooked shrimp are not appropriate to determine product safety concerning pathogens
because an APC analysis does not detect anaerobes that grow and produce C. botulinum toxin and product internal temperature alone would not determine the food safety hazard of pathogen growth and toxin formation to include C. botulinum. Also, you do not identify the action you would take when product is over 40°F and was found outside FDA time/temperature guidelines .
In addition to determining the safety of the product, FDA also recommends that your corrective action plans include provisions for determining and correcting the cause of the deviation to ensure that the critical control point(s) is (are) under control.
4. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123 .6(c)(4). However, your firm's HACCP plan for "Pasteurized Seafood" does not list adequate monitoring procedures at the Product Storage and Storage (of finished product) critical control points to control the food safety hazard of pathogen growth and toxin formation to include C botulinum. FDA recommends that, in addition to the use of a 24 hour chart recorder, you perform a visual check of the instrument at least once per day.
You must immediately take appropriate steps to correct the violations . We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
Please 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 deviations. You may wish to include in your response documentation such as copies of the revised HACCP plan, HACCP monitoring records, or other useful information that would assist us in evaluating your corrections. If you cannot complete ail corrections before you respond, we expect that you will explain the reason for your delay, and state when you will correct any remaining deviations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations and the current Good Manufacturing Practices requirements (21 CFR Part I 10). You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Your response should be directed to: Ms. Erlinda N. Figueroa, Compliance Officer, U.S. Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA 94502-7070 .
If you have any questions regarding any issue in this letter, please contact Ms. Figueroa at (510) 337-6795.
Barbara J. Cassens
San Francisco District
cc: Harry W. Barrett, Quality Assurance Manager
We note that although you do not list the critical control points, your plan includes critical limits that may
be associated with them.