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U.S. Department of Health and Human Services

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Enforcement Actions

Carry All Provisions Inc 8/8/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
13-PHI-28
 
 
 
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
 
August 8, 2013
 
 
Daniel R. Boscia, President and Co-Owner
Carry All Provisions, Inc.
98 Vanadium Road
Bridgeville, PA 15017
 
Dear Mr. Boscia:
 
We inspected your seafood processing facility, located at 98 Vanadium Road, Bridgeville, PA on July 16, 2013 through July 19, 2013. 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 ready-to-eat (RTE) refrigerated canned pasteurized crabmeat and RTE refrigerated seafood salads in five (5) pound  containers are adulterated in that 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 regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
 
We acknowledge receipt of your response on July 29, 2013; however, it failed to provide documentation regarding the disposition of the RTE refrigerated seafood items that you had in stock during the time of the inspection. At the close of the inspection, you informed our investigator that your firm was planning to discontinue the sale and distribution of refrigerated seafood items and that you were going to return the products, currently in stock, to your supplier and/or destroy them on site. As stated above, your response letter did not address or include records which document the return and/or destruction of the RTE seafood products that you were selling, during the time of the inspection.   
 
Your significant violations were as follows:
 
1.    You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). However, your firm does not have a HACCP plan for RTE refrigerated canned pasteurized crabmeat and RTE refrigerated seafood salads in five (5) pound containers to control the food safety hazard of pathogen growth and toxin formation; specifically, Clostridium botulinum.
 
When conducting your hazard analysis, your firm should assess those steps that are reasonably likely to result in Clostridium botulinum growth and toxin formation due to time/temperature abuse. For example, receipt of refrigerated products will likely be critical to ensure that proper temperatures were maintained during the transit period to your facility. In addition, refrigerated finished product storage will likely be critical to ensure proper temperatures are maintained during extended storage periods. FDA recommends the use of equipment capable of monitoring and recording refrigerated temperatures on a 24 hour a day/7 day a week basis, with a daily check of the temperature records and a daily check of the equipment. For additional information and guidance in developing a HACCP plan, please refer to the Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition (the Hazard Guide).

2.    You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c).  However, your firm does not maintain any sanitation monitoring records. Under 21 CFR 123.11(c), you are required to maintain, at a minimum, sanitation records that document the monitoring of the following conditions and corrections: 1) the safety of water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; 2) condition and cleanliness of food contact surfaces; 3) prevention of cross-contamination from insanitary objects to food; 4) maintenance of hand washing, hand sanitizing, and toilet facilities; 5) protection of food, food packaging material, and food contact surfaces from adulteration from chemical, physical, and biological contaminants; 6) proper labeling, storage, and use of toxic compounds; 7) control of employee health conditions; and 8) exclusion of pests.

3.    You failed to maintain adequate refrigeration to prevent the growth of undesirable microorganisms in food, as required by 21 CFR 110.93. Specifically, your firm’s walk-in cooler containing seafood products was observed by our investigator, on July 16, 2013, to be at (b)(4)F on both the dial thermometer inside the cooler as well as the cooler’s built in thermometer located on the outside of the cooler door.  
 
As stated above, FDA recommends the use of equipment capable of monitoring and recording refrigerated temperatures on a 24 hour a day/7 day a week basis, with a daily check of the temperature records and a daily check of the equipment. 
 
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 in violation of Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)) and the seafood HAACP regulation. 
 
This letter may not list all the violations in your facility.  You are responsible for ensuring that your firm 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. In addition to consulting the Act and Title 21 of the CFR, further guidance and information on regarding Seafood HACCP can be accessed on FDA’s website at: http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006764.htm and http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Seafood/ucm2018426.htm
 
Please 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 your HACCP plans and any records that document your activities as a domestic processor, 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.
 
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.
 
Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above.  If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.         
 
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District 
 
cc:   
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
Attention: Dr. Lydia Johnson, Director
2301 North Cameron Street
Harrisburg, PA 17110-9408