Kelley's Katch 4/6/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||New Orleans District|
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
April 6, 2012
WARNING LETTER NO. 2012-NOL-17
UNITED PARCEL SERVICE
Delivery Signature Requested
Michael C. Kelley, Co-Owner
Vickie S. Kelley, Co-Owner
210 Washington Street
Savannah, Tennessee 38372-7515
Dear Mr. and Mrs. Kelley:
On February 7-9, 2012, investigators with the U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 210 Washington Street, Savannah, Tennessee. Investigators found 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 which 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 United States Code (21 USC) Part 342(a)(4)]. Accordingly, your paddlefish roe (caviar) and paddlefish products are adulterated because 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 regulation, and the Fish and Fisheries Product Hazards & Controls Guidance
through links on FDA’s Internet home page at www.fda.gov
On February 9, 2012, FDA investigators issued a FORM FDA 483, Inspectional Observations (FDA 483), to Vickie S. Kelley, Co-Owner. Significant violations listed include the following:
1. Failure for your HACCP plan to list monitoring procedures which ensure compliance with the critical limit [21 CFR 123.6(c)(4)]. Your paddlefish caviar HACCP plan identifies the addition of salt, per your Salt Chart, to 4%. You process your own caviar and add caviar that has already been salted. The one analysis you had performed by an outside laboratory resulted in findings of salt content at 3.42%. The water phase salt was analyzed and identified at 5.98%. These findings are unacceptable, as is the one yearly analysis.
2. Failure to implement the monitoring procedures listed in your HACCP plan [21 CFR 123.6(b)]. You failed to provide any documentation which shows your firm is monitoring the temperature critical limit of less than or equal to 37 degrees F at the point of receiving salted roe from outside vendors critical control point for prevention of the significant hazard Clostridium botulinum toxin formation, as described in your paddlefish caviar HACCP plan.
3. Failure to include the date and time of the activity on the record and signature or initials of the person performing the operation [21 CFR 123.9(a)]. Fourteen circular temperature recording charts, covering a 14 week time span, and showing the continuous monitoring of the cooler temperature were not individually identified by date and did not include the signature or initials of the individual monitoring the temperature of the cooler.
4. Failure of your verification procedures to include, at a minimum, ongoing verification activities including calibration of process monitoring instruments and review of monitoring, corrective action, and calibration records [21 CFR 123.8(a)(2)]. The verification procedures listed in your paddlefish caviar HACCP plan do not include calibration of thermometers/temperature monitoring instruments, and review of monitoring records, corrective action and calibration records at each critical control point in your HACCP plan.
5. Failure to review some of your critical control point monitoring records within one week after the records were made [21 CFR 123.8(a)(3)]. Monitoring records for significant hazard Clostridium botulinum toxin formation, as listed on your paddlefish caviar HACCP plan, are not signed indicating they have been reviewed by the HACCP trained individual. Records include salt and temperature, which are significant critical control points for Clostridium botulinum toxin.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product and/or enjoin your firm from operating.
Please note FDA has recently published a 4th edition of the “Fish and Fisheries Products Hazards and Controls Guidance.” This new publication provides the most current information to assist processors in developing their HACCP plans. For specific information on the hazard of Clostridium botulinum toxin formation, please refer to Chapter 13.
Section 743 of the Act [21 USC 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection which identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, [21 USC 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
You should 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 violations. You should include in your response documentation such as HACCP and verification records, or other useful information which 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 your processing plant operates in compliance with the Act and the seafood HACCP regulation (21 CFR 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to Kari L. Batey, Compliance Officer, U.S. Food and Drug Administration, at the above address. If you have questions about this letter, please contact Ms. Batey at (615) 366-7808.
Patricia K. Schafer
New Orleans District