Public Health Service Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
May 1, 2015
Mr. Anders E. Gustaffson
Cemco International Corp
3016 NE 12th Terrace
Ft. Lauderdale, FL 33334
Dear Mr. Gustaffson:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility located in Ft. Lauderdale, FL, from March 18-24, 2015. 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 canned pasteurized crabmeat is adulterated, in that it have been prepared, packed, or held under insanitary conditions whereby theymay 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 are as follows:
1. You must have a HACCP plan that 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, your firm’s HACCP plan for pasteurized canned crabmeat lists a critical limit, “to be receved [sic] at 40 F and transit time less than 4 hours”, at the receiving critical control point that is not adequate to control C. Botulinum toxin and pathogen growth. FDA recommends at the receiving critical control point that all lots received are accompanied by truck records that show the temperature is maintained at or below 40 degrees F.
2. You must have a HACCP plan that lists a monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for pasteurized canned crabmeat lists a monitoring procedure(s)/frequency at the receiving critical control point that in not adequate to control C. Botulinum toxin and pathogen growth.
You list a monitoring procedure of “…thempurature [sic] of truck at delivery with date and time” with “thermometer, calibrated. If transport more than 4 hours temp. Monitoring device must be included” for “each lot”. FDA recommends temperature of truck refrigerated compartment with digital time and temperature logger for continuous, with visual review and evaluation of temperature monitoring records for each shipment.
3. You must implement the monitoring procedures and frequency listed in your HACCP plan to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring frequency of continuous recordings at the storage critical control point to control C. Botulinum toxin and pathogen growth listed in your HACCP plan for pasteurized canned crabmeat. For example, your continuous monitoring system for the temperature in cooler (b)(4) has not worked since December 2014. As of 03/18/15 your monitoring system was not functional.
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.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s 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 U.S.C. § 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: 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.