Inspections, Compliance, Enforcement, and Criminal Investigations

Performance Food Group Inc 10/12/17

 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Food Operations West Division 3
4040 North Central Expressway, Suite 300
Dallas, Texas 75204 

 
 

 

October 12, 2017
 
2018-DAL-WL-01
 
WARNING LETTER
 
UPS Overnight
 
Craig H. Hoskins, President and CEO
Performance Food Group Customized
12500 West Creek Parkway
Richmond, VA 23238
 
Dear Mr. Hoskins,
 
We inspected your seafood warehouse located at 500 Metro Park Drive, McKinney, TX between the dates of August 15, 2017 and August 21, 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 U.S.C. § 342(a)(4). Accordingly, your ready-to-eat, canned, pasteurized crabmeat is adulterated, in that it has been prepared, packed, or held under conditions whereby it may have been rendered injurious to health. 
 
You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov.
 
At the conclusion of the inspection on August 21, 2017, your firm was issued a FDA 483, Inspectional Observation. We acknowledge receipt of your response, dated September 11, 2017. Your response will be made a permeant record in your firm’s file.
 
Your significant deviations are 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 the significant hazards of C. Botulinum and pathogen growth when you firm deviated from your HACCP plan’s critical limit at the Receiving CCP. Specifically, your written HACCP plan for pasteurized crabmeat states that product will be maintained at ≤40°F during transit and upon receipt; however, a review of your firm’s pasteurized crabmeat receiving log and the time/temperature indicator record for the dates of July 14, 2017 and July 20, 2017 revealed that your firm deviated from your critical limit without taking a corrective action that ensured the product did not enter interstate commerce and that your firm had regained control over the operation. For example:
 
a.  On July 14, 2017, the time/temperature indicator record showed that the ambient temperature of the trailer exceeded your critical limit of 40°F for approximately 16 hours with a high temperature mark of approximately 43°F. Your firm received the shipment of pasteurized crabmeat without conducting a time/temperature assessment and without conducting a corrective action. The product was later distributed into commerce.
 
b.  On July 20, 2017, the time/temperature indicator record showed that the ambient temperature of the trailer exceeded your critical limit of 40°F for approximately 72 hours with a high temperature mark of approximately 45°F. Your firm received the pasteurized crabmeat without conducting a time/temperature assessment of the product and without conducting a corrective action. The product was late distributed into commerce.
 
We have reviewed your response letter dated September 11, 2017. We acknowledge that your firm has conducted additional HACCP training with a focused effort on the pasteurized crabmeat receiving form. However, this response is inadequate because your firm has not conducted a time/temperature assessment of the effected lots of canned pasteurized crabmeat received on the dates of July 14, 2017 and July 20, 2017 that exceeded your critical limit of 40°F. Further you have not conducted an assessment of other lots of product not reviewed by the Investigator. 
 
2.    You must review critical control point monitoring records within one week after the records are made, to ensure compliance with 21 CFR 123.8(a)(3). Specifically, you did not review your pasteurized crab receiving record and the time/temperature indicator record for the dates of July 14, 2017 and July 20, 2017. On these dates, your firm received cases of pasteurized crabmeat from a trailer with an ambient air temperature that exceeded your firm’s critical limit of 40°F. In addition, these monitoring records did not receive a verification review.
 
We acknowledge that your firm has conducted additional training on the proper use of the pasteurized crabmeat receiving form. You further state that thermometer calibration logs have been reviewed, signed and dated. The agency will evaluate the implementation of this corrective action during the next inspection.
 
3.    Because you chose to include a corrective action within your HACCP plan, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b). However, your corrective action plan listed for your Crab, Crawfish, & Lobster Pasteurized and Reduced Oxygen” HACCP plan at the Receiving critical control point is not appropriate as follows. Specifically, your corrective action for “Crab, Crawfish, & Lobster Pasteurized and Reduced Oxygen” HACCP plan list the following corrective action at the Receiving CCP:
 
“REJECT IF AIR TEMPERATURE ˃40°F FOR ˃4hours on TTR REJECT if product temperature ˃40°F when transit time <4hrs and no TTR Verified Weekly by HACCP Trained Individual”
 
This corrective action is inadequate as it does not state how your firm will regain control of the operation after a critical limit deviation has occurred. FDA recommends this corrective action include discontinuing use of the carrier until evidence is obtained that transportation and handling practices have been improved.
 
We acknowledge within your firm’s response that you state that your corrective action for critical control point 1 will be updated to include notifying the vendor of rejection. However this corrective action is inadequate because you have not provided an updated pasteurized crabmeat HACCP plan for are review. Further it is not only important to notify the supplier of the deviation but also to discontinue the use of the supplier until evidence is obtained that transportation and handling practices have been improved.  
 
The violations cited in this letter are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment and the products that you manufacture are in compliance with all requirements of the Act and federal regulations. It is your responsibility to review all products that you manufacture and distributes commercially to determine if they are subject to seafood HACCP regulations (21 CFR 123). 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.
 
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 response to Paul E. Frazier, Compliance Officer, U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have questions regarding any issues in this letter, please contact Mr. Frazier at (214) 253-5340 or by email at Paul.Frazier@fda.hhs.gov.   
 
 
Sincerely,
/S/                                                           
Edmundo Garcia Jr.
District Director
Program Division Director
Office of Human and Animal Food, WD3
                       
 
 
Cc:       Lori Woznicki, Food and Drug Inspections Branch Manager
            Division of regulatory Services
             Texas Department of State Health Services
            1100 E. 49th Street – Mail Code 1987
            Austin, Texas 78756
 
Cc:       Mr. Jeff A. Jacks, Warehouse Manager
            Performance Food Group Inc.
            500 Metro Park Drive
             McKinney, TX 75071-1883
 
            Mr. Tom Hoeffel, Regional Vice President
            Performance Food Group Inc.
            500 Metro Park Drive
            McKinney, TX 75071-1883

Page Last Updated: 10/23/2017
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