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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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North American Caviar Company 21-Feb-02

DEPARTMENT OF HEALTH AND HUMAN SERVICES

New Orleans District Office

6600 Plaza Drive, Suite 400

New Orleans, LA 70127

February 21, 2002

VIA FEDERAL EXPRESS

Warning Letter No. 02-NSV-15

Kenneth D. Linsman, Owner

North American Caviar Company

78 Barnhill Lane

Paris, TN 38242

Dear Mr. Linsman:

We inspected your firm, located at 78 Barnhill Lane, TN, on January 8-10, 2002 and found that you have serious deviations from the Seafood HACCP regulations (21 CFR part 123). These deviations, some of which were previously brought to your attention, cause your fish roe to be in violation of section 402(a)(4) of the federal Food, Drug, and Cosmetic Act (the Act). You can find this Act and the Seafood HACCP regulations through links in FDA?s home page at www.fda.gov.

The deviations were as follows:

Failure to have and implement a written HACCP plan to control the hazards associated with processed roe manufactured and receive, by your firm, as required by 21 CFR 123.6(b).

You must adequately monitor and sanitation conditions, practices and corrections during

processing, to comply with 21 CFR 123.11(b)and (c). Your sanitation records do not indicate the time the sanitation checks are performed and the person conducting the check is not identified. In addition, your firm did not monitor possible routes of cross-contamination and the protection of food and adulteration as evidenced by:

1. Non-food grade fiberglass screen was used to drain roe.

2. Employee was not washing and sanitizing hands after handling insanitary objects and then mixing roe.

3. Employees were not wearing hair and beard restraints.

4. Finished product containers were store on a rusty shelf without further washing and sanitizing.

We acknowledge that you submitted a response, dated January 14, 2002, concerning our investigator?s observations noted on the Form FDA 483. We have reviewed your response and have the following comments:

The HACCP plan that you submitted to control the hazards of chemicals and Clostridium botulinum in processed roe manufactured and received by your film is not adequate. The problems found in your response indicate that you may need to see help from an outside expert who is qualified in seafood HACCP. For instance,

  • Finished product storage has not been identified as a critical control point to control C. botulinum.
  • The critical limits are inadequate to control C. botulinum at the processing and receiving critical control points.
  • The critical limit is inadequate to control chemicals at the receiving critical control point.
  • The monitoring procedures are inadequate to control C. botulinum at the receiving critical control point.
  • The corrective actions listed in your HACCP plan are inadequate to control C. botulinum at the processing and receiving critical control points.
  • The corrective actions listed in your HACCP plan are inadequate to control chemicals at the receiving critical control points.
  • The verification procedures listed in your HACCP plan are inadequate to control C. botulinum at the processing and receiving critical control points.

We also noted that your bulk roe labeling does not have a refrigeration statement or include a statement of identity. Processed roe with less than 20% water phase salt, packaged in reduced oxygen packaging must be labeled with a statement such as, "IMPORTANT Must Be Kept Refrigerated To Maintain Safety".

This letter may not list all the deviations at your firm. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations, the Current Good Manufacturing Practice regulations (21 CFR 110), and labeling regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You will find the regulations and guidance documents at http://www.cfsan.fda.gov/~dms/flp-toc.html and http://www.cfsan.fda.gov/~lrd/fr970224.html.

You should take prompt action to correct these violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, seizure injunction.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the steps you have taken to correct the violations. For corrections that you cannot complete within the fifteen (15) working days, state the reason for the delay and your timeframe for completion. We also ask that you provide documentation of the corrections as they are made, including copies of any revised labels, and that you explain your plan for pr venting these violations in the future.

Please send your reply to the Food and Drug Administration, Attention: Karen Gale Sego, Compliance Officer, 297 Plus Park Boulevard, TN 37217.

Sincerely,

Carl E. Draper

Director, New Orleans District