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  5. Pagano's Inc. - 11/12/2014
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WARNING LETTER

Pagano's Inc. Nov 12, 2014

Pagano's Inc. - 11/12/2014


Recipient:
Pagano's Inc.


United States

Issuing Office:
New England District Office

United States


  

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

Public Health Service
Food and Drug Administration
 New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556 

 

WARNING LETTER
 
 CMS # 443191
 
                                                                                                           
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
 
November 12, 2014
 
 
Alan R. Pagano, President
Pagano’s Inc.
142 Water Street
Norwalk, CT 06854  
           
                                                           
Dear Mr. Pagano:
 
We inspected your seafood processing facility, located 142 Water Street, Norwalk, CT on October 7, 2014, October 8, 2014, and October 10, 2014. 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. 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 fish and fishery products, including your ready-to-eat refrigerated vacuum packed cold and hot smoked salmon, caviar, seafood salads, pasteurized canned crabmeat, and herring in cream and in wine sauce 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 regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
 
We acknowledge the receipt of your firm’s letter, dated October 22, 2014, in response to the form FDA-483, Inspectional Observations, issued during the inspection of your firm on October 10, 2014. We address this response below, in relation to the noted violations.
 
Your significant violations were as follows:
 
1.    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 plans for  “Smoked Product & ready to eat products (caviar, seafood salads)”, “Pasteurized/Fresh Crab Meat”, and “Histamine Fish Group” each list the critical limit, “(b)(4)”, at the “(b)(4)” critical control point that is not adequate for controlling the food safety hazards of Clostridium botulinum growth and toxin formation and pathogenic bacteria growth and toxin formation (other than Clostridium botulinum) as a result of time and temperature abuse.
 
Specifically, during our inspection we found;
  • Ready-to-eat refrigerated vacuum packed cold-smoked salmon is received at your firm with ice packs in the cartons and the transit time exceeds four hours.
  • Ready-to-eat refrigerated vacuum packed cold and hot smoked salmon are received at your firm under refrigeration and the transit time is less than four hours.
  • Ready-to-eat refrigerated caviar is received at your firm with ice packs in the cartons and the transit time exceeds four hours.
  • Ready-to-eat refrigerated seafood salads are received at your firm under refrigeration and the transit time is less than four hours.
  • Ready-to-eat refrigerated pasteurized canned crabmeat is received at your firm under refrigeration and the transit time is less than four hours.
  • Ready-to-eat refrigerated herring in cream and in wine sauce are received at your firm under refrigeration and the transit time is less than four hours.
Your October 22, 2014 response is not adequate since you did not address all the deficiencies observed and your revised HACCP documents do not adequately address this violation.   FDA recommends that strategies for controlling the food safety hazards of Clostridium botulinum growth and toxin formation and pathogenic bacteria growth and toxin formation (other than Clostridium botulinum) as a result of time and temperature abuse at the transit/receiving critical control point should include one of the following strategies chosen based on your specific product’s process;
  • For fish or fishery products delivered refrigerated (not frozen): All lots received are accompanied by transportation records that show that the product was held at or below 40°F (4.4°C) throughout transit. Note that allowance for routine refrigeration defrost cycles may be necessary;
  • For products delivered under ice: Product is completely surrounded by ice at the time of delivery;
  • For products delivered under chemical cooling media, such as gel packs: There is an adequate quantity of cooling media that remain frozen to have maintained product at 40°F (4.4°C) or below throughout transit; AND The internal temperature of the product at the time of delivery is 40°F (4.4°C) or below; 
  • For products delivered refrigerated (not frozen) with a transit time (including all time outside a controlled temperature environment) of 4 hours or less (optional control strategy): Time of transit does not exceed 4 hours; AND internal temperature of the product at the time of delivery does not exceed 40°F (4.4°C).
Also, in accordance with 21 CFR 123.6 (b)(2), firms may group kinds of fish and fishery products together, or group kinds of production methods together, if the food safety hazards, critical control points, critical limits, and procedures required to be identified are identical for all fish and fishery products so grouped or for all production methods so grouped. Your revised HACCP plans group multiple fish and fishery products and the grouped products do not have identical processes.
 
2.    You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the (b)(4)” and “(b)(4)” critical control points to control the food safety hazard of Clostridium botulinum growth and toxin formation listed in your HACCP plan for “Smoked Product & ready to eat products (caviar, seafood salads)”.
 
Specifically, during our inspection we found your firm did not record any receiving monitoring observations from at least August 1, 2014 to September 1, 2014 or any refrigerated storage monitoring observations from at least August 10, 2014 to August 30, 2014. During our inspection we observed in your refrigerated storage cooler, 30 packages of ready-to-eat refrigerated vacuum packed cold-smoked salmon which was received on or about August 26, 2014.
 
Your October 22, 2014 responseindicates that you will ensure that personnel are properly trained to conduct monitoring and record keeping functions when key firm management are not available. This observation was discussed with your firm during previous inspections and promises to correct were not implemented.
 
3.    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 food safety hazard of Clostridium botulinum growth and toxin formation when your refrigerated storage temperature for ready-to-eat refrigerated vacuum packed cold-smoked salmon deviated from your critical limit at the “(b)(4)” critical control point listed in your HACCP plan for “Smoked Product & ready to eat products (caviar, seafood salads)”.   
 
Specifically, during our inspection we found your “(b)(4)” critical control point monitoring and verification records indicated frequent and continuous temperature excursions up to 50oF between September 1, 2014 and October 4, 2014 and you did not take corrective actions accordingly. During our inspection we observed in your refrigerated storage cooler, 30 packages of ready-to-eat refrigerated vacuum packed cold-smoked salmon which was received on about August 26, 2014.
 
Your October 22, 2014 response is not adequate since it does not address this issue. To date there is no information or documentation that indicates you have adequately evaluated the safety of your high risk fishery products, including ready-to-eat refrigerated vacuum packed cold-smoked salmon, stored in your refrigerated storage cooler based on the potential adverse time and temperature exposures identified in your continuous monitoring records.
 
4.    Because you chose to include a corrective action plan 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 ready-to-eat refrigerated vacuum packed cold-smoked salmon at the “(b)(4)” critical control point to control the food safety hazard of Clostridium botulinum growth and toxin formation is not appropriate.
 
Specifically, your HACCP plan for “Smoked Product & ready to eat products (caviar, seafood salads)” which includes your ready-to-eat refrigerated vacuum packed cold-smoked salmon lists at the “(b)(4)” critical control point the corrective action of “(b)(4)”. Your corrective actions are not adequate. In reduced oxygen packaged products, including ready-to-eat refrigerated vacuum packed cold-smoked salmon, in which the spores of non-proteolytic Clostridium botulinum are inhibited or destroyed a normal refrigeration temperature of 40°F (4.4°C) is appropriate because it will limit the growth of proteolytic Clostridium botulinum and other pathogens that may be present. You must take appropriate corrective actions whenever a critical limit is exceeded. FDA recommends one of the following corrective actions strategies should be taken whenever the critical limits listed in your HACCP plan are exceeded at the refrigerated storage CCP; 
  • Chill and hold the affected product until an evaluation of the total time and temperature exposure is performed; OR Destroy the product; OR Divert the product to a non-food use.
And
  • Move some OR all of the product in the malfunctioning cooler to another cooler; OR Freeze the product;
And
  • Address the root cause: Make repairs or adjustments to the malfunctioning cooler; OR Make adjustments to the ice application operations. AND Prevent further deterioration: Add ice to the product;
Your October 22, 2014 response is not adequate since it does not address this issue and the revised HACCP plans you provided continue to list corrective actions that are not appropriate.
 
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.
 
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 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.
 
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 send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 781-587-7619.
 
 
Sincerely,
/S/ 
Mutahar S. Shamsi
District Director
New England District

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