Inspections, Compliance, Enforcement, and Criminal Investigations
Harvey Kliebert Plant 11-Feb-04
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New Orleans District
6600 Plaza Drive, Suite 400
New Orleans, LA 70127
February 11, 2004
WARNING LETTER NO. 2004-NOL- 14
Mr. Harvey J. Kliebert, Owner
Harvey Kliebert Plant
41067 West Yellow Water Road
Hammond, Louisiana 70403
Dear Mr. Kliebert:
On November 19 - 20, 2003, we inspected your seafood processing facility, located at 41067 West Yellow Water Road, Hammond, Louisiana. We found that you have a serious deviation from the Seafood Hazard Analysis 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 frozen, vacuum-packaged alligator meat is adulterated, in that the alligator meat has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act and the Seafood HACCP regulations through links in FDA?s Internet home page at http://www.fda.gov .
The deviation was 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 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 frozen alligator meat does not list the food safety hazard of Clostridium botulinum (C. botulinum) toxin formation, which is reasonably likely to occur during the expected shelf-life of your product under your present practices.
C. botulinum toxin formation would not be reasonably likely to occur and thus would not need to be included in your HACCP plan if actions such as the following are taken:
We may take further action if you do not correct this violation promptly. For instance, we may take further action to seize your products and/or enjoin your firm from operating.
We are aware that you made a verbal commitment to correct the deviations during the inspection. Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. You should include in your response documentation such as your revised HACCP plan, product labels, or other useful information that would assist us m evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and stale 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 regulation and the Current Good Manufacturing Practice regulation, 21 CFR 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 U.S. Food and Drug Administration, Attention: Mark W. Rivero, Compliance Officer, at the address above. If you have questions regarding any issue in this letter, please contact Mr. Rivero at (504) 253-4519.
Patricia K. Schafer
Acting District Director
New Orleans District
Enclosure: Form FDA 483