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U.S. Department of Health and Human Services

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Enforcement Actions

United States Cold Storage, Inc. 12/1/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
 
Telephone: 407-475-4700
FAX: 407-475-4770


 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
 
FLA-12-11
 
December 1, 2011
 
Robert Bayliff, Operations Manager
United States Cold Storage, Inc.
11801 NW 102nd Road
Medley, FL 33178
 
Dear Mr. Bayliff:
 
We inspected your seafood processing establishment, located in Medley, FL from October 12-17, 2011. 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 Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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 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 pasteurized crab, amberjack/yellowtail, herring, mackerel, mahi mahi, smoked fish, and smoke flavored, salted fish 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 regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
 
Your significant violations were as follows:
 
1.      You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However,
 
a.       Your firm’s revised HACCP plan for “pasteurize crab meat” lists a critical limit, “product must be less than 40 °F”, at the receiving critical control point that is not adequate to control pathogenic bacteria growth and Clostridium botulinum toxin formation. This critical limit does not ensure that these products were not held under temperature abuse conditions during transit.
 
b.      Your firm’s HACCP plan for “smoked fish, smoked flavored, salted fish” lists a critical limit, “Product must be at or below 38°F”, at the “receive fresh” critical control point that is not adequate to control pathogenic bacteria growth and Clostridium botulinum toxin formation. This critical limit does not ensure that these products were not held under temperature abuse conditions during transit.
 
c.       Your firm’s revised HACCP plan for “amberjack/yellowtail, herring, mackerel, mahi mahi” lists a critical limit, “product must be less than 40°F”, at the receiving critical control point that is not adequate to control pathogenic bacteria growth and Clostridium Botulinum, and scombrotoxin (histamine) formation. This critical limit does not ensure that these products were not held under temperature abuse conditions during transit.
 
This is a repeated violation as cited on the Form FDA 483, Inspectional Observations (Observation 3), during the FDA inspection conducted at your facility from June 22-27, 2007 and described in a letter to you (Citation 2) dated October 3, 2007.   
 
2.      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,
 
a.       Your revised corrective action plans for “amberjack/yellowtail, herring, mackerel, mahi mahi” at the receiving and storage critical control points to control pathogenic bacteria growth and Clostridium Botulinum, and scombrotoxin (histamine) formation is not appropriate. Your corrective action plans at the receiving critical control point of “place product on hold and call customer for further instructions” and at the storage critical control point of “place product on hold, call customer immediately for further instructions” do not address correcting the cause of the deviation. 
 
This is a repeated violation as cited on the Form FDA 483 (Observation 5) during the FDA inspection conducted at your facility from June 22-27, 2007.   
 
b.      Your corrective action plan for “smoked fish, smoked flavored, salted fish” at the receiving critical control point to control pathogenic bacteria growth and Clostridium botulinum toxin formation is not appropriate. Your corrective action plan of “place product on hold. Contact customer immediately” does not address correcting the cause of the deviation.  
 
c.       Your revised corrective action plan for “pasteurize crab meat” at the receiving critical control point to control pathogenic bacteria growth and Clostridium botulinum toxin formation is not appropriate. Your corrective action plan of “place product on hold, call customer immediately for further instructions” does not address correcting the cause of the deviation. 
 
3.      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 and pathogenic bacteria growth and toxin formation as a result of time and temperature abuse when your process for canned pasteurized crab meat deviated from your critical limit at the refrigerated storage critical control point. 
 
For example, canned, pasteurized crab meat was held at temperatures that exceeded 40 degrees Fahrenheit during the following time periods: April 9, 2011 at 21:30:00 through April 11, 2011 at 08:30:01; June 22, 2011 at 16:15:02 through June 28, 2011 at 12:30:03; September 30, 2011 at 09:30:02 through October 6, 2011 at 10:00:00. Your firm took no corrective action on the product held in the cooler under these conditions and an immediate corrective action was not taken to correct the cooler temperature when it was above 40 degrees Fahrenheit.
 
Specifically, your firm received canned, pasteurized crab meat on April 15, 2011 that was stored at temperatures above 40 degrees Fahrenheit. The product was then shipped into interstate commerce on July 19, 2011.
 
We received your response dated November 15, 2011 to the Form FDA 483 issued to and discussed with you at the close of the inspection on October 17, 2011. Your response does not adequately address the significant observations on the Form FDA 483. We have reviewed your revised HACCP plans as described above.
 
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 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 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.
 
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 Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 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: Andrea H. Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Ms. Norwood by telephone at (407) 475-4724.  
 
Sincerely,
/S/
Emma R. Singleton
Director, Florida District