- Southern Aire Seafood, Inc.
- Issuing Office:
- New Orleans District Office
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New Orleans District
404 BNA Drive
Building 200- Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366·7802
February 8, 2017
Warning Letter no. 2017-NOL-05
UNITED PARCEL SERVICE
Delivery Signature Requested
Mary C. Lyons, President
Southern Aire Seafood, Inc.
9626 Irvington Bayou La Batre Highway
Irvington, Alabama 36544
Dear Mrs. Lyons:
On November 1 – 4, 2016, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, located at 9626 Irvington Bayou La Batre Highway, Irvington, Alabama. We found you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123, and the Current Good Manufacturing Practice (CGMP) regulation for foods, 21 CFR 123. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan which 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 (USC) 342(a)(4)]. Accordingly, your ready-to-eat crabmeat and stuffed seafood products are adulterated because 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 on FDA's internet home page at www.fda.gov.
We acknowledge receipt of your written response, received in our office on November 21, 2016, to the deviations observed during the inspection and listed on the Form FDA 483, Inspectional Observations (FDA 483) issued to you on November 4, 2016. We have evaluated your response and discuss your corrective actions relative to each item below.
The significant violations were as follows:
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 crabs deviated from your critical limit at the (b)(4) critical control point. Specifically, your written HACCP plan for Fresh Picked crab meat states you would cook crabs at a rolling boils for a minimum of (b)(4) however, a review of your Daily Cook Log demonstrates you did not take corrective action that ensured the affected product was segregated, a review of the affected product was done to determine its acceptability, affected product was not entered into commerce, and the cause of the deviation was corrected:
a. On August 23, 2015, Cook # 1 was one (1) minute short of the (b)(4)
b. On August 23, 2015, Cook # 3 was six (6) minutes short of the (b)(4)
c. On August 23, 2015, Cook # 12 was one (1) minute short of the (b)(4)
d. On April 27, 2016, Cook # 3 was two (2) minutes short of the (b)(4)
e. On April 29, 2016, Cook # 3 was two (2) minutes short of the (b)(4)
f. On May 4, 2016, Cook # 4 was five (5) minutes short of the (b)(4)
g. On May 4, 2016, Cook # 6 was two (2) minutes short of the (b)(4)
h. On May 4, 2016, Cook # 7 was one (1) minute short of the (b)(4); and,
i. On May 25, 2016, Cook # 7 was eight (8) minutes short of the (b)(4)
You explain in your written response you explain that correction action sheets have been made and you trained your employees. Although you begin to address our concerns, you failed to provide the correction action sheets. In addition, you failed to address your assessment of the crabmeat released into commerce which may have received an inadequate cook time, or the results of your record review.
2) You must implement the monitoring procedures and frequency you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not record monitoring observations at the (b)(4) critical control point to control (b)(4) listed in your HACCP plan for ready-to-eat crab meat. Specifically, you have no monitoring records for backing and cooling operations during the following dates: August 21, 2015; August 24, 2015; August 25, 2015; August 26, 2015; August 27, 2015; September 28, 2015; June 1, 2016; and, August 19, 2016.
You explain in your written response that you are implementing an electronic time system and you revised your backing/cooking logs. You failed to provide a copy of the revised backing /cooking logs and a more detailed explanation of how your electronic time system will be implemented to correct the deviation.
3) You must have a HACCP plan that, at 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 control 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’ HACCP plan for cooked ready-to-eat crabmeat does list a critical limit, (b)(4) at the (b)(4) critical control point that is not adequate to control (b)(4)
You explain in your response that HACCP papers have been reviewed and revised. You failed to provide the revised HACCP plan to address the deviation.
4) Since you have chosen to include corrective actions 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 cooked ready-to-eat crabmeat at the (b)(4) critical control point to control (b)(4) is not appropriate. Your HACCP plan lists a corrective action, (b)(4). This corrective action would not ensure that affected product would not enter into commerce and the cause of the deviation corrected.
You explain in your response the HACCP papers have been revised; however, you failed to provide the revised HACCP plan.
5) You must monitor sanitation conditions and practices during processing with sufficient 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 prevention of cross-contamination from insanitary objects and exclusion of pests with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 110 as evidenced by:
A. The employee was observed to handle an unwashed/unsantizied door handle, and dolly handle then contact cooked crabs and ice (used to cool cooked crabs) without first washing or sanitizing his hands between contacts on three occasions on November 3, 2016.
B. A white plastic pipe used to cool and wash cooked crabs contained a green, brown, and black material. Water was observed contacting these materials and cooked and cooked crab parts.
C. Water droplets were repeatedly observed to drop from a rusty motor onto cooked crabs during backing operations.
D. The chlorine solution at two hand sanitizing stations used to sanitize employees hands were tested with results indicating less than 10 ppm for the presence of chlorine. Employees were observed to repeatedly use the stations to sanitize their hands, gloves, and equipment prior to contacting cooked crabs and cooked crab contact surfaces.
E. You are not monitoring the cleanliness of food contact surfaces as evidenced by previously cooked crab parts from operations on the previous day and after cleaning operations were observed on the metal conveyor were observed to come into direct contact with newly cooked crabs on the conveyor belt.
F. On November 3, 2016, an employee was observed to repeatedly only sanitize one of her hands. The employee was observed to contact cooked crab meat and cooked crab meat contact surfaces with the unsanitized hand.
G. A water hose, which did not contain a back flow prevention device, was observed to be submerged in a container used to sanitize employee’s hands and equipment.
H. You used two metal rakes to move cooked crabs and cooked crab part. The rakes contained a hole in the shaft, allowing water and other debris to enter the interior of the shaft which could not be adequately cleaned or sanitized. In addition, employees were observed to contact the end of the rakes then contact cooked crabs, cooked crab parts and cooked crab contact surfaces without washing their hands or gloves prior to contact.
I. The metal conveyor belt used to transport cooked crabs has missing pieces, broken pieces, and pieces of metal that can penetrate cooked crab and cooked crab parts.
J. Five unlabeled containers of a blue liquid were stored in the picking and packing room during operations. Several employees were observed to use the liquid in the container to wash their hands and gloves prior to sanitizing.
You provided the following corrective actions to the deviations noted above:
- You explain in your written response that your dollies have been labeled and employees that handle trash do not handle cooked crab.
- You explain in your written response that the PVC pipe has been removed and cleaned. Employees trained to keep PVC pipe cleaned and sanitized.
- You explain that a tray has been built and installed to prevent water droplets.
- You explain that you trained employees to change the water and use chlorine test strips to monitor chlorine.
- You provided excessive training to your employees.
- You installed a back flow prevention device on the hose.
- You installed end caps on rakes.
- You removed and replaced with new labeled containers.
Although your proposed corrective actions begin to address the Agency’s concerns, you failed to provide any evidence supporting your actions. Your corrective action will be confirmed during an inspection at a later date.
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123) and the CGMP regulation (21 CFR 110). You are responsible for preventing further violations of the Act and all applicable regulations. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the violations. You should include in your response documentation such as your revised HACCP plan, sanitation records, or other useful information which 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.
Section 743 of the Act, [21 USC 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 non-compliance 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 USC 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 non-compliance 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: Mark W. Rivero, Compliance Officer, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 846-6103.
Ruth P. Dixon
New Orleans District