Inspections, Compliance, Enforcement, and Criminal Investigations
Esh Foods LLC 02-Jun-06
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REOUESTED
June 2, 2006
Mr. David E. Esh, Owner
Esh Foods LLC
58 Hatville Road
Gordonville, PA 17529-9758
Dear Mr. Esh:
We inspected your seafood processing facility, located at the above address on April 3, 7, 13, and 20, 2006. 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 ready-to-eat cream cheese containing surimi seafood 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 through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
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 cream cheese spreads containing surimi seafood, does not list critical control points to control pathogen growth, for the thawing of frozen surimi seafood, and .the storage of the finished product cream cheese spreads containing surimi seafood.
Further, after critical control points are established, 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 control 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.
We note that your HACCP plan for cream cheese spreads containing shrimp is very similar to your HACCP plan for cream cheese spreads containing surimi seafood. We suggest that you evaluate both of these plans concurrently.
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.
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.
Please send your reply to the Food and Drug Administration, Attention Rhonda J. Walley, Compliance Officer, at the address noted in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Walley at 215-717-3079.
Thomas D. Gardine
Philadelphia District Office . . . .