Inspections, Compliance, Enforcement, and Criminal Investigations
Riddle Brothers 4/27/12
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 27, 2012
WARNING LETTER NO. 2012-NOL-19
UNITED PARCEL SERVICE
Delivery Signature Requested
William E. Riddle, Co-Owner
120 North Spring Street
Hornbeak, Tennessee 38232-5142
Dear Mr. Riddle:
The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility, located at 120 North Spring Street, Hornbeak, Tennessee, on March 2 and 12, 2012. We found 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 (CGMP) 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 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 (USC) 342(a)(4)]. Accordingly, your Paddlefish, Sturgeon, or Bowfin roe product is adulterated, because 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 on FDA's Internet home page at www.fda.gov.
Your significant violations were as follows:
1. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control Clostridium botulinum (C. botulinum) growth and toxin formation when your process for Paddlefish, Sturgeon, or Bowfin roe deviated from your critical limit at the Salt Processing critical control point (CCP). Specifically, the last record of testing performed is documented as June 7, 2010, which revealed you did not meet your critical limit of (b)(4) water phase salt. On June 7, 2010, (b)(4) samples (b)(4) of Paddlefish and Sturgeon Caviar were analyzed. The laboratory analysis report documents water phase salt levels at (b)(4) and (b)(4) for your Paddlefish Caviar; and, (b)(4) and (b)(4) for your Sturgeon Caviar. You did not perform any corrective actions to identify and correct the cause of your process not meeting your critical limit, to prevent the deviation from occurring again, and to prevent potentially unsafe product from being distributed.
Furthermore, since 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 Paddlefish, Sturgeon, or Bowfish roe at the Salt Processing CCP to control C. botulinum growth and toxin formation is not appropriate. Your corrective action instructs to (b)(4). An appropriate corrective action plan describes the steps to be taken and assigns responsibility for taking those steps, to ensure: 1) no product enters commerce that is either injurious to health or is otherwise adulterated, as a result of the deviation; and, 2) the cause of the deviation is corrected.
2. You must implement the monitoring procedures and frequency which you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedure of (b)(4) at the Salt Processing CCP to control C. botulinum growth and toxin formation listed in your HACCP plan for Paddlefish, Sturgeon, or Bowfish roe. Specifically, the last record of analysis is documented as June 7, 2010, which revealed your finished product did not meet your critical limit of (b)(4) water phase salt.
3. You must implement the record keeping system which you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the Salt Processing CCP to control C. botulinum growth and toxin formation listed in your HACCP plan for Paddlefish, Sturgeon, or Bowfish roe. Specifically, your HACCP plan requires annual calibration of your temperature recording device; however, your firm does not maintain records documenting annual calibration of any temperature recording device.
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with CGMP requirements in 21 CFR 110, to comply with 21 CFR 123.11(b). However, your firm does not monitor or maintain sanitation records documenting: 1) the safety of water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; 2) maintenance of hand washing, hand sanitizing, and toilet facilities; 3) protection of food, food packaging material, and food contact surfaces from adulteration by means of lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; 4) proper labeling, storage, and use of toxic chemicals; and, 5) exclusion of pests from the food facility.
Additionally, your firm failed to properly store equipment, remove litter and waste, and cut weeds and grass that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of your plant facility, to ensure compliance with CGMP requirements in 21 CFR 110. Specifically, on March 2, 2012, our investigator observed the following on your food facility grounds: a pile of lumber; a freezer box; plastic jugs; crates; nets; untrimmed bushes, approximately four to eight feet tall, growing against an exterior wall; milk crates; a bucket; a screen; a pan; coolers; a tire; and, more. Your food facility grounds must be kept in a condition that will protect against the contamination of food.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) 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 steps you have taken to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information to 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 123) and the CGMP regulation (21 CFR 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act (21 USC 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance 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 domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the U.S. Food and Drug Administration, Attention: Rebecca A. Asente, Compliance Officer, at the address above. If you have questions regarding issues in this letter, please contact Ms. Asente at (504) 832-1290 extension 1104.
Patricia K. Schafer
New Orleans District