Eckerd Seafood, Inc.
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Atlanta District Office |
60 Eighth Street, NE
Atlanta, GA 30309
November 1, 2010
VIA UNITED PARCEL SERVICE
William (Bill) K. Eckerd, President
Eckerd Seafood, Inc.
1033 McIntosh Industrial Blvd., SW
Darien, GA 31305
(11- ATL -02)
Dear Mr. Eckerd:
We inspected your seafood processing facility, located at 1033 McIntosh Industrial Blvd., Darien, GA on 6/15-17/10. We collected a sample of pasteurized crabmeat during this inspection and received the laboratory analysis on 6/25/10. 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 fresh pasteurized crabmeat, fresh crabmeat, vacuum packed fresh or smoked fish and scombrotoxin species fish are adulterated, in that they have been prepared, packed, or held under insanitary conditions, whereby they may 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:
- You must have a HACCP plan that, at a minimum, lists 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 “fresh pasteurized crabmeat, fresh crabmeat, vacuum packed fresh or smoked fish” lists a monitoring procedure(s)/ frequency at the storage critical control point that is not adequate to control pathogen growth and toxin formation.
Your HACCP plan states that the critical limit for the cooler temperature will not exceed (b)(4) for more than (b)(4) hours, with a monitoring frequency of visually checking (b)(4) times per day.
Based on the monitoring frequency listed in the plan, your firm will be unable to meet the listed critical limit that is based on (b)(4) hour intervals because you will only have 3 temperature data points per 24 hour period, rather than (b)(4) temperature data points with temperatures taken every (b)(4) hour in a 24 hour period. FDA recommends that in order to ensure that the cooler temperatures do not rise above the listed critical limits for an extended time period that firms use equipment capable of monitoring and recording cooler temperatures on a 24 hour a day/7 day a week basis with a daily check of the record and of the equipment.
- 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, your firm’s HACCP plan for fresh pasteurized crabmeat, fresh crabmeat, vacuum packed fresh or smoked fish lists a critical limit (s), of (b)(4), at storage critical control point that is not adequate to control pathogen growth and toxin formation. FDA recommends that for control of pathogen growth, firms maintain products at or below 40ºF.
- 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 pathogen growth or toxin formation when your process for storing pasteurized crabmeat deviated from your critical limit at the storage critical control point. Your firm did not take a corrective action when on 6/15/10 the temperature of your firm’s cooler storage area exceeded 60 degrees F.
- You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the processing area with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by the presence of at least 4 flies in the processing area on both 6/15 & 16/10. These flies were observed alighting on processing tables, vats containing fish, the refuse can, and on the walls.
Our investigator collected a sample of the pasteurized crabmeat stored in the cooler described in item #1 in which she noted the temperature in the cooler to exceed 60 degrees F on her first day of inspection. This sample #616165 (b)(4) pasteurized crabmeat hand picked) Manufacturing Code 9146*** USE BY JUL 31 2011 was analyzed by our FDA laboratory for decomposition. Our laboratory findings were that out of 18 subs examined for decomposition, 9 of the subs failed for decomposition. We called you to report the test results and inquire as to what your intentions were as to the status of the product. At that time you informed us that you were going to recall this lot, however our recall coordinator has not yet received the recall information that he requested from you. Please provide us with your recall notification to your customers as well as the distribution list for this affected lot. A copy of our analytical laboratory worksheets is attached.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your products 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 of 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, Serene N. Ackall, Compliance Officer, 60 Eighth St., NE, Atlanta, GA 30309. If you have questions regarding any issues in this letter, please contact Ms. Ackall at 404-253-1296.
John R. Gridley, Director