Hopkins, E Frank Co., Inc. 9/18/12

WARNING LETTER
12-PHI-30

OVERNIGHT MAIL      
RETURN RECEIPT REQUESTED

September 18 2012

Stephen L. Marmer, Owner/President
Hopkins, E Frank Co., Inc.
3427 S Lawrence Street
Philadelphia, PA 19148-5615     

Dear Mr. Marmer:

We inspected your seafood processing and importer establishment, located at 3427 S Lawrence Street on August 16, 2012 through August 27, 2012.  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 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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).   

As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12.  In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123.  If assurances do not exist that the imported fish or fishery products have been processed under conditions equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. §342(a)(4). 

Accordingly, your fish and fishery seafood products 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 (the guide) Fourth Edition – April 2011, through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b).   However, your firm did not monitor the condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, and protection of food, food packaging material, and food contact surfaces from adulteration with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110, as evidenced by:

• On August 17, 2012, our investigator observed an employee cutting histamine forming fish, specifically bluefish and tuna, directly beside another employee who was cutting non-histamine forming fish, specifically croakers, bronzini, and wild rock fish.  The employee cutting the histamine forming fish was observed dumping a full tote of water over the tuna and the water from the tuna flowed into the croakers.  In addition, your employees failed to follow your written SSOP’s that state (b)(4)
• On August 17, 2012, our investigator observed employees placing boxes and bags of bluefish, rock fish, and hake fish directly on the processing table prior to dumping the seafood out of them for processing.  When the boxes and bags were removed from the table, there was dirty appearing pooled water left behind on the processing table.  These fish were processed on the table, which was not cleaned and sanitized.
• On August 17, 2012, our investigator observed an employee prop a running hose directly on hake fish, process other hake fish, and then remove the hose and processed the hake fish that was directly under the hose.
• On August 17, 2012, our investigator observed that none of the employee’s processing fish had been observed washing their hands, changing their gloves, or using the hand dip consistently.  Further these employee’s failed to follow your written SSOP’s which states: (b)(4)

2. You must have a HACCP plan that, at a minimum, lists the critical limits (CL) that must be met at each of the critical control points (CCP) to comply with 21 CFR 123.6(c)(3).  A CL 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 plan for pasteurized, canned crabmeat lists a CL, “surface Temp. (b)(4) or less using Laser Therm” at the receiving CCP that is not adequate to control the hazard of Clostridium botulinum and toxin formation.  Taking the surface temperature of this incoming product alone is not an effective means of controlling the hazard of Clostridium botulinum and toxin formation that might have occurred during transportation from the supplier, as this CL will not provide any information about the handling of the fish prior to receipt. Specifically, your firm imported this product under entry number (b)(4) on or about January 2012, via ocean carrier over several weeks, from Indonesia.  You were unable to provide our investigator with the temperature monitoring records for this product, for that time period. FDA recommends that you include CL’s associated with the receipt of fish that will either require records indicating how the fish were handled during transit, such as continuous recording of temperature during transit of over 4 hours in addition to your current CL, to control the hazard of Clostridium botulinum and toxin formation [FDA-483 Observation #2]. 

3. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point (CCP), to comply with 21 CFR 123.6(c)(4).  However,

a. Your firm’s HACCP plan for pasteurized, canned crabmeat lists monitoring procedure(s)/frequency at the receiving CCP that is not adequate to control Clostridium botulinum and toxin formation.  Specifically, the receiving CCP lists the monitoring procedure of temperature of incoming product with a digital thermometer, taking (b)(4) temperatures for each lot.  This procedure does not ensure compliance with the CL of surface temperature of fish being (b)(4) or (b)(4), in that it fails to take into account whether this CL is met when transportation of the product is greater than four hours [FDA-483 Observation #3a].

b. Your firm’s HACCP plans for pasteurized, canned crabmeat, histamine-forming fish species, and vacuum packed and/or smoked fish products list monitoring procedure(s)/frequency at the chilled storage CCP that are not adequate to control Clostridium botulinum and toxin formation (crabmeat and vacuum packed/smoked fish) and histamine formation (histamine forming fish species).  Specifically, the chilled storage CCP lists monitoring procedures of checking the cooler temperature (b)(4) with a digital thermometer.  This procedure does not ensure compliance with the CL’s of (b)(4) or (b)(4).  FDA recommends that you measure the temperature of the cooler using a continuous method such as using a digital time/temperature data logger with a frequency of continuous monitoring by the instrument itself, with visual check of the instrument at least once per day [FDA-483 Observation #3b].

4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each CCP, to comply with 21 CFR 123.6(c)(4).  However, your firm’s HACCP plan for vacuum packed and/or smoked fish does not list the monitoring frequency at the receiving CCP to control the hazard of Clostridium botulinum and toxin formation [FDA-483 Observation #3c].

5. 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 “receiving” CCP to control the hazard of Clostridium botulinum listed in your HACCP plan for pasteurized, canned crabmeat.  Our investigator was informed that the firm does not record the (b)(4) temperature checks that are taken upon receipt of each lot of this product [FDA-483 Observation #5a].

6. You must implement the monitoring procedures and frequencies that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4).  However, your firm did not follow the monitoring procedure/frequency of (b)(4) at the “chilled storage” CCP to control Clostridium botulinum listed in your HACCP plan for pasteurized, canned crabmeat and vacuum packed and/or smoked fish; and pathogen growth and histamine formation in your HACCP plan for histamine forming fish. Specifically, the investigator observed that in practice, your firm documents a manual check of the temperatures in the coolers (b)(4).  In addition cooler temperatures are not documented at all on weekends or holidays, and on days when the firm is very busy, as evidenced by the lack of  monitoring records on July 4, 30, 2012 and August 6, 7, 8, 2012 [FDA-483 Observation #5b].

7. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.8(a).  However, your firm did not verify the adequacy of the CL of “all fish having internal temp at (b)(4) for histamine producing fish, at the receiving CCP to control the hazard of pathogen growth and histamine formation.  Your HACCP plan states that quarterly lab analysis will be performed as a verification procedure.  On August 27, 2012, our investigator was informed that the firm does not perform this testing [FDA-483 Observation #5c]. 

8. You must take an appropriate corrective action when a deviation from a CL occurs, to comply with 21 CFR 123.7(a).  However, your firm did not take a corrective action to control the hazard of Clostridium botulinum and toxin formation when your processes for pasteurized, canned crabmeat and vacuum packed smoked fish deviated from the CL, at the chilled storage CCP.  Specifically;

a. Your (b)(4) continuous data records for the (b)(4) (cooler) (b)(4), used to warehouse pasteurized, canned crabmeat, show temperatures above the CL of (b)(4) on April 23, 2012 at (b)(4) until (b)(4), with a range of (b)(4) to (b)(4) and on August 8, 2012 at (b)(4) until (b)(4), with a range of (b)(4) to (b)(4). Your firm exceeded your CL at the chilled storage CCP and there were no records to show that a corrective action was taken.  Further, these products were distributed in interstate commerce [FDA-483 Observation #6a].

b. Your (b)(4) continuous data records for the Trailer (b)(4) , used to warehouse vacuum packed smoked fish, show temperatures above the CL of (b)(4) on January 6, 2012 at (b)(4) until January 13, 2012 at (b)(4) with a range of (b)(4) and on January 31, 2012 at (b)(4) until (b)(4), with a range of (b)(4).  Your firm exceeded your CL at the chilled storage CCP but there were no records to show that a corrective action was taken [FDA-483 Observation #6b].

9. 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:

a) Pasteurized, canned crabmeat, at the chilled storage CCP to control Clostridium botulinum and toxin formation is not appropriate.  Your HACCP plan lists “if cooler exceeds (b)(4) check product temp.  If ok remove to another cooler”.  Your corrective action does not ensure that adulterated product does not enter commerce and that the cause of the deviation is corrected [FDA-483 Observation #9a].
b) Histamine forming fish at the chilled storage CCP to control the formation of histamine formation is not appropriate.  Your HACCP plan lists “if temp exceed (b)(4) then each lot of fish will be examined for ice & internal temp will be checked for (b)(4).  Your corrective action does not ensure that adulterated product does not enter commerce and that the cause of the deviation is corrected [FDA-483 Observation #9b].
c) Vacuum packed and/or smoked fish products, at the chilled storage CCP to control Clostridium botulinum and toxin formation is not appropriate.  Your HACCP plan lists “if cooler exceeds (b)(4) check product temp.  If ok remove to another cooler.“  Your corrective action does not ensure that adulterated product does not enter commerce and that the cause of the deviation is corrected [FDA-483 Observation #9c].

10. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and (c)(1).  A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, physical property that may cause a food to be unsafe for human consumption.”  However, your firm’s HACCP plan for pasteurized, canned crabmeat does not list the food safety hazard of Clostridium botulinum and toxin formation at the CCP of chilled storage [FDA-483 Observation #8].

11. You must have product specifications that are designed to ensure that the fish and fishery products that you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm imports pasteurized, canned crabmeat and frozen shrimp from Indonesia and frozen tilapia from the Republic of China,  and you do not have product specifications to address the biological, chemical and physical safety attributes for these products.  Further, our investigator informed you that your firm should also have “written” verification procedures that outline the components of verification to include product specifications and the affirmative steps that your firm will take for each imported product [FDA-483 Observation #10].

We may take further action if you do not promptly correct these violations.  For instance, we may take further action to refuse admission of your imported fish or fishery products  under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.

In addition to the observations noted above, we have serious concerns regarding the following:  Your firm imported a shipment of crabmeat under Entry # (b)(4) from Indonesia, which you received on or about February 3, 2012.  The shipment consisted of (b)(4) types of crabmeat, totaling (b)(4).  As noted in item #2 above, your firm was unable to provide monitoring records to our investigator to assure that the products were held at safe temperatures, specifically at (b)(4) during the entire ocean voyage, which began on or about December 29, 2011 and ended on or about  February 3, 2012.  Our investigator documented that a portion of these released products were stored in your (b)(4) cooler (b)(4) and she also documented that your (b)(4) continuous data records indicated that the product temperatures exceeded your HACCP plan CL of (b)(4), at the chilled storage CCP from April 23, 2012 at (b)(4) until (b)(4), with a temperature range of (b)(4).  You informed our investigator that this product was distributed on April 24, 2012 and provided her with invoices of approximately (b)(4) consignee’s.  Further, you informed our investigator that these products were from the same shipment and were returned by your consignee’s  due to a foul odor and swollen cans.  We acknowledge that these returned goods (b)(4) were voluntarily destroyed by your firm during the inspection, however we are concerned that you did not deem it necessary to determine the disposition of the  remainder of the distributed shipment.  In addition, our investigator noted returned product in the cooler with varying lot #’s, some of which were still within their expiration date. Your written “Recall Procedures” state that a (b)(4).  Please include with your response, your rationale for not conducting a recall of these products. 

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 importer verification records, records that document the performance and results of your firm’s affirmative steps, HACCP and verification records associated with 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.

This letter may not list all the violations at your facility.  You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and 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 for your fish or fishery products, including those that you import into the United States.

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 written response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above.  If you have questions regarding any issues in this letter, please contact Compliance Officer Bonner at 215-717-3074 or by e-mail at Lynn.Bonner@fda.hhs.gov.
 

Sincerely,

/S/

Kirk D. Sooter
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