Inspections, Compliance, Enforcement, and Criminal Investigations
Wannemacher Enterprises 6/1/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Cincinnati District Office
6751 Steger Dr.
Cincinnati, OH 45237
VIA United Parcel Service
June 1, 2012
Ronald R. Miller, President & CEO
R & L, Inc.
3745 Shawnee Rd.
Lima, OH 45806
WARNING LETTER CIN-DO 12-310138
Dear Mr. Miller:
We inspected your seafood processing facility, located at 422 W. Guthrie St., Upper Sandusky, OH on March 28 – April 17, 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 spray dried seafood products 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 regulations, 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 firm’s response dated April 25, 2012. However, the response is not adequate because the significant violations cited below have not been corrected.
- 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 spray dried seafood products does not list finished product labeling as a critical control point for controlling the food safety hazard of allergens.
- 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 dried seafood products does not list the monitoring frequency at the drying critical control point to control the food safety hazard of pathogen growth and toxin formation.
- 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, your corrective action plan for dried seafood products at the drying critical control point to control pathogens is not appropriate. Specifically, your corrective action plan does not assure that affected product does not enter commerce and the cause of the deviation is corrected.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm complies with the Act, the seafood HACCP regulation (21 CFR Part 123), and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You should take prompt action to correct these violations. Failure to correct these violations in a prompt manner may result in regulatory actions without further notice, such as seizure, injunction, and/or prosecution.
Additionally, the inspection referenced above identified violations materially related to the food safety requirements of the Act. Accordingly, Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs associated with reinspection. A reinspection is one or more inspections conducted following an inspection that identified noncompliance materially related to the food safety requirements of the Act, specifically to determine whether compliance has been achieved. Reinspection costs include 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. FDA will assess and collect fees associated with this reinspection in accordance with Section 743 of the Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your reply should be sent to the U. S. Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 6751 Steger Dr., Cincinnati, OH 45237. You should include in your response documentation such as HACCP plans, HACCP monitoring 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.
If you have questions regarding any issue in this letter, please contact Karen Gale Sego, Compliance Officer, at (513) 679-2700 extension 2164.
Paul J. Teitell
cc: Charles Kirchner, Chief, Food Safety Division
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399
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