Inspections, Compliance, Enforcement, and Criminal Investigations

J & B Seafood Inc. 9/19/17

 

  

Black HHS-Blue FDA Logo

 

 

Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237
Telephone: (513) 679-2700
              FAX: (513) 679-2772

 

 
 

 

September 19, 2017
 
Amended Warning letter 535742
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Raymond T. Barbour
Owner/President
J & B Seafood, Inc.
9301 Faith Street
Coden, Alabama 36523-3057
 
Dear Mr. Barbour:
 
We inspected your seafood processing facility, located at 9301 Faith Street, Coden, Alabama, on June 19-23, 2017. 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 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 United States Code § 342(a)(4). Accordingly, your fresh picked crabmeat is adulterated, in that 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 in FDA's Internet home page at www.fda.gov.
 
Your significant violations were as follows:
 
Seafood HACCP:
 
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 pathogen survival when your process for cooked crabmeat deviated from your critical limit at the cooking critical control point.  Specifically, your written HACCP plan for crabmeat states you would cook crabs at a (b)(4); however, a review of your Daily Cooking Log demonstrates you did not take corrective action that ensured the affected product was segregated, held for evaluation to determine acceptability, re-cooked and the cause of the deviation was corrected:

Log Date
Cook Number
Cook Time
6/16/17
7
(b)(4)
6/14/17
8
(b)(4)
5/12/17
5
(b)(4)
4/26/17
8
(b)(4)
1/5/17
1
(b)(4)
8/5/16
1
(b)(4)
8/5/16
2
(b)(4)
8/5/16
3
(b)(4)
8/5/16
4
(b)(4)
8/5/16
5
(b)(4)
8/5/16
6
(b)(4)
8/5/16
7
(b)(4)
8/5/16
9
(b)(4)
8/5/16
10
(b)(4)
7/2/16
1
(b)(4)
7/2/16
2
(b)(4)
7/2/16
3
(b)(4)
7/2/16
4
(b)(4)
7/2/16
5
(b)(4)
7/2/16
6
(b)(4)

 
2.    You must monitor sanitation conditions and practices during processing frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR 110 to comply with 21 CFR 123.11(b).  However, your firm did not monitor sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
 
a.  Live flies observed in the picking room that repeatedly landed on cooked crabs, cooked crab parts and cooked crab food contact surfaces. 
b.  Our investigators observed a foreign black material encrusted in the etching of your etched handled knife after it was washed and sanitized. 
c.  Our investigators observed three employees cooking and preparing crab with unrestrained hair. Additionally, an employee was repeatedly observed wiping her nose while touching cooked crabs without washing her hands.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action such as seizure or injunction, without further notice.
 
Additional Comment:
 
During the inspection our investigators noted that your firm utilizes a vacuum packaging process on your frozen lump crabmeat. This packaging method creates an increased potential for the formation of the Clostridium botulinum (C. botulinum) toxin. Your packaging is required to meet the minimum recommended oxygen transmission rate of 10,000 cc/m²/24hrs (e.g. 1.5 mil polyethylene) to eliminate the hazard of C. botulinum. Consequently, depending upon the packaging used, your firm may need to identify and control the C. botulinum hazard. If identified, your firm should control this hazard by ensuring that all packages of your vacuum packed, frozen crab products are labeled with handling instructions such as “Keep Frozen, Thaw Under Refrigeration Immediately Before Use” to control toxin formation in frozen products. 
 
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 respond to this office in writing within 15 working days from your receipt of this letter. In your response, identify the procedures you have taken or will take to completely correct the current violations and prevent similar ones. Please include an update and documentation of your corrective actions as noted above. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the timeframe in which you will complete the corrections.
 
Please send your reply to Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have questions regarding any issues in this letter, please contact Ms. Hunter at (516) 679-2700 extension 2134 or Allison.hunter@fda.hhs.gov.
 
Sincerely,
/S/ 
Steven B. Barber
Director, Division V
Office of Human and Animal Food Operations-East

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