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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Above Sea Level 8/13/10

  

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

Public Health Service
Food and Drug Administration
 Southwest Region
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3551 

August 13, 2010


Ref: DEN-10-15 WL


WARNING LETTER


VIA UPS


Mr. Jeffery S. Koscomb, Owner/President
Above Sea Level
1274 Calle De Comercio Ste#1
Santa Fe, New Mexico 87507


Dear Mr. Koscomb:

We inspected your seafood processing facility, located at 1274 Calle De Comercio Ste#1, Santa Fe, New Mexico, on June 16-17, 2010. 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, and the Current Good Manufacturing Practice 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 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 vacuum packaged and pasteurized canned crab meat along with fresh yellowtail and ono (wahoo) 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 conduct, or have conducted for you, a hazard analysis for each kind of fish and fishery product that you process to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonable likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for refrigerated vacuum packaged and pasteurized canned crab meat to control the hazard of pathogen growth and toxin formation from the growth of Clostridium botulinum. Specifically, our investigators observed these fishery products in your cooler during the inspection.
 

2. You must implement the monitoring procedures and frequency that 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 procedures "each delivery, each lot, 1 fish ea. box" at the receiving critical control point to control histamine toxin listed in your HACCP plan for scombrotoxin (histamine) forming fish. Specifically, your receiving records document that you only checked one box for the adequacy of ice and one fish in that box for its internal temperature, which is not consistent with your procedure to monitor the internal temperature of one fish in each lot (i.e., each box). Furthermore, there is no documentation for how many boxes of tuna were received on 12/15/2009 on your receiving record.


 In addition, you receive yellowtail, ono (wahoo), and escolar fish that are scombrotoxin (histamine) forming fish but are not listed in your HACCP plan. As such these species need to be added to your HACCP plan and you must implement and record monitoring observations for these histamine forming fish.


3. 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, your corrective action plan for scombrotoxin (histamine) forming fish at the storage critical control point to control the formation of histamine toxin is not appropriate. Specifically, your HACCP plan lists the corrective action as "adjust cooler" and /or "add ice" if the temperature of the cooler is above the critical limit. Adjusting the cooler and/or adding ice after the products have been temperature abused are not appropriate because these actions do not ensure that the adulterated products do not enter commerce. The corrective actions fail to list what you will do with the affected fishery product.


When conducting your hazard analysis your firm should assess those steps that are reasonably likely to result in Clostridium botulinum growth and toxin formation due to time/temperature abuse. For example, receipt of refrigerated products will likely be critical to ensure that proper temperatures were maintained during the transit period to your facility. In addition, refrigerated finished product storage will likely be critical to ensure proper temperatures are maintained during extended storage periods.


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 Food and Drug Administration, Attention: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have,any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303) 236-3024.
 

Sincerely,

/S/

Harry T. Warwick, Jr.

Denver District Director