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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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B&A Seafood 11/29/12

  

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-05

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

                                                                  November 29, 2012


Mr. Robert L. Fister, Co-Owner/Treasurer
B&A Seafood
3419 S. Lawrence Street
Philadelphia, PA  19148-5615

Dear Mr. Fister:

We inspected your seafood processing establishment, located at 3419 S. Lawrence Street, Philadelphia, PA on September 28, 2012 through October 11, 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 123 and 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 with 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 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:

HACCP Violations:

1.  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 temperatures at the “receiving” critical control point (CCP), at the time of receipt or before distribution, to control the hazard Clostridium botulinum for your ready to eat pasteurized, canned crabmeat; and histamines for your scombrotoxin forming species products listed in your HACCP plan [FDA-483 Observation #1a & #1b, respectively].  For example:

a. On September 7, 2012, (b)(4) cans of pasteurized, canned lump crabmeat (warehouse lot (b)(4)) were received and partially distributed, but the product temperatures for the HACCP Receiving Form were not documented until October 1, 2012 (16 working days after receipt of product).

b. On September 20, 2012, (b)(4) of Mahi Mahi were received, and completely distributed, but the product temperatures for the HACCP Receiving Form were not documented until October 1, 2012 (7 days after receipt of product).

c. Our investigator observed that from August 24, 2012 through September 28, 2012, product temperatures for your HACCP Receiving Form, which is required by the  receiving CCP in your HACCP plans for ready to eat seafood products and  scombrotoxin species, were documented on September 1, 2012.

d. Record review of the HACCP Receiving Form since June 21, 2012, revealed product receipts were not consistently documented with receiving temperatures.  For example; six (6) out of nineteen (19) receipts for scombrotoxin species of fresh fish were not documented.

2.  You must implement the monitoring procedures and frequency that you have listed in your HACCP plan to comply with 21 CFR 123.6(b) and (c)(4).  Your firm’s HACCP plan for RTE Seafood Products, and Scombrotoxin Species lists a critical limit temperature of (b)(4) at the “storage” CCP.  However, your firm failed to enforce this CCP during hours of operation (b)(4). Additionally, cooler temperatures are often above critical limits [FDA-483 Observation #1c].  For example:

a.   On October 3, 2012, the electronic thermometer in Cooler (b)(4) read (b)(4) at 12:15pm and (b)(4) at 12:35pm.  During this time, Spanish Mackerel was stored.

b.  On October 2, 2012, at 1:08 pm, the digital wall thermometer in Cooler (b)(4) read (b)(4). Using a calibrated handheld thermometer, the FDA investigator observed a reading of (b)(4). During this time, Bluefish was stored.

c.  On October 3, 2012, at 10:18 am, the electronic thermometer in the (b)(4) Cooler read (b)(4). During this time, pasteurized, canned crabmeat was stored.

3.  You must make available for FDA review and copying at reasonable times all mandatory records, plans and procedures required under 21 CFR 123 to comply with 21 CFR 123.9(c).  However, a representative of your firm was unable to make available for FDA review Cooler Temperature and Sanitation Forms from October, 2010 through November, 2011.  During this time, scombrotoxin species of fresh fish, including Bluefish and Mahi Mahi, were cut and stored in the coolers [FDA-483 Observation #2].

4.  You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plans for ready to eat seafood products, and scombrotoxin species lists monitoring procedures/frequencies at the receiving CCP that are not adequate to control the hazards Clostridium botulinum and toxin formation, and histamine formation, respectively [FDA-483 Observation #3a & #3b].  For example:

a. The receiving CCP requires a product temperature to be taken if the adequacy of (b)(4) is not documented. However, your pasteurized, canned crabmeat is not received (b)(4) and the adequacy of (b)(4) at the receipt of scombrotoxin species of fresh fish is not documented. The monitoring procedure involves recording the product temperature of “each lot” received, but does not ensure that the critical limit is met. This procedure does not ensure compliance with the critical limits of (b)(4) for pasteurized, canned crabmeat, and (b)(4) for scombrotoxin species fresh fish, in that it fails to take into account whether this critical limit is met when transportation of the product is less than or greater than four hours.

b. The cooler storage CCP lists a monitoring frequency (for recording the cooler temperature) of (b)(4) when in operations.  This frequency does not ensure that the critical limit is met, in that the coolers are not equipped with continuous temperature recording devices.  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. 

5.  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 reasonable 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 fresh crabmeat packaged in plastic tubs to control the food safety hazard of pathogen growth, specifically, Listeria monocytogenes [FDA-483 Observation #4].

6.  You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a).  For example,

a. Your firm did not take a corrective action to control histamine formation when your processes for Scombrotoxin Species fresh fish deviated from the critical limit, at the cooler storage CCP. Your Cooler Temperature and Sanitation Form for Cooler (b)(4) and Cooler (b)(4), used to warehouse Scombrotoxin Species, show temperatures above the CL of (b)(4)  Specifically, on May 5, 2012, the temperature was recorded at (b)(4) and on July 10, 2012; July 18, 2012 and September 6, 2012, the temperature was recorded at (b)(4) respectively. Your firm exceeded your CL at the cooler storage CCP and there were no records to document that a corrective action was taken.  Further, these products were distributed into commerce [FDA-483 Observation #5a].

b. Your firm did not take a corrective action to control Clostridium botulinum and toxin formation when your processes for pasteurized, canned crabmeat deviated from the critical limit, at the cooler storage CCP. Your Cooler Temperature and Sanitation Form for the (b)(4) Cooler, used to warehouse Ready to eat Seafood Products, show temperatures above the CL of (b)(4).  Specifically, on May 28, 2012, the temperature was recorded at (b)(4). Your firm exceeded your CL at the cooler storage CCP and there were no records to document that a corrective action was taken. Further, these products were distributed into commerce [FDA-483 Observation #5b].   

7.  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) [FDA-483 Observation #6].  However, regarding your corrective action plans for:

a. RTE Seafood Products (Pasteurized Crab Meat, Smoked Vacuum Packed Fish):

At the receiving critical control point, you indicate if the “temperature exceeds the critical limit but doesn’t exceed (b)(4) the product is (b)(4) “If the receiving temperature exceeds (b)(4), the product is (b)(4). However, the corrective action to control “Pathogen growth C. bot”, is not appropriate, in that the plan does not describe how the products will be evaluated if the receiving temperature exceeds the recorded amount, and the plan does not ensure the cause of the deviation is corrected.

b. Scombrotoxin Species (Bluefish, Hamachi, Mahi, Macks & Tuna):

At the receiving critical control point, you indicate if the “temperature exceeds the critical limit of (b)(4), but doesn’t exceed (b)(4), the product is (b)(4) “If the receiving temperature exceeds (b)(4), the product is (b)(4). However, the corrective action to control Scombrotoxin (histamine) formation, is not appropriate, in that the visual examination alone is not capable of detecting increased levels of scombrotoxin, and the plan does not ensure the cause of the deviation is corrected.

c. RTE Seafood Products (Past. Crab Meat, Smoked Vacuum Packed Fish):

 At the cooler storage critical control point, you indicate if the “storage temperature  exceeds the critical limit, the product is (b)(4) and (b)(4)  However, the corrective action does not describe the criteria for cumulative time/temperature exposure, and the plan does not ensure that the cause of the deviation is corrected.  Additionally, you do not address correcting the cause of the malfunction in  the cooler.

d. Scombrotoxin Species (Bluefish, Hamachi, Mahi, Macks & Tuna):

At the cooler storage critical control point, you indicate if the “storage temperature exceeds the critical limit, the product is (b)(4)  However, the plan does not require withholding affected product from distribution until its safety can be evaluated, also the plan does not ensure that the cause of the deviation is corrected.

CGMP Violations:

8.  You failed to use adequate freezing and refrigeration to destroy or prevent the growth of undesirable microorganisms in food.  Specifically, your long term refrigeration storage process of cold smoked vacuum-packed salmon fails to control the hazard of Listeria monocytogenes [21 CFR 110.80(b)(4); FDA-483 Observation #13].

9.  You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices (CGMP), including prevention of cross-contamination from insanitary objects; proper labeling, storage, use of toxic chemicals; safety of water, and food contact surfaces to comply with 21 CFR 110.35 [FDA-483 Observations #11 & #12, respectively].  However, you firm failed to comply as evidenced by the following:

a. Prevention of Cross-contamination:

i. On September 28, 2012, knives were observed stored wedged in an un-cleanable area between the back lip of the cutting table and the wall.  Operators then used the knives to cut fresh grouper without cleaning.

ii. On September 28, 2012 and October 2, 2012, swordfish was observed uncovered in Cooler (b)(4) in a large lined cardboard box without a lid.

iii. On October 2, 2012, Salmon was observed uncovered in Cooler (b)(4) in a large Styrofoam container without a lid.

b.  Proper Labeling, Storage, and Use of Toxic Chemicals:                                                

i. On September 28, 2012, two unlabeled spray bottles containing clear liquid were observed in the cutting room.  One bottle was used to spray the cutting table between cutting grouper and salmon. The liquid was later identified as (b)(4).                                                                      

c.  Safety of Water that comes into contact with food or food contact surfaces:                                              

i. On September 28, 2012, a plastic hose and un-cleaned scaling tool were observed submerged in a small bin of water. The water was running from the main plumbing line through the hose and into the bin.                                                    

d.  Maintenance of hand washing, hand sanitizing, and toilet facilities:                                         

i. Fish cutting employees are trained not to use the sink in the cutting room for hand washing.  After washing their hands, the employees must pass through plastic curtains to reenter the cutting room.  On September 28, 2012, the curtains were observed to contain visible residue and had not been cleaned for approximately (b)(4).                                                                        

e.  Protection of food, food packaging material, and food contact surfaces:                                                   

i. On September 28, 2012, a unlabeled, spray bottle of (b)(4) was observed hanging directly above an uncovered tray of whiting on the cutting table.                                                               

10.  You do not provide hand washing and hand sanitizing facilities at each location in the plant to comply with 21 CFR 110.37(e)(1) [FDA-483 Observation #14]:

a. No operational hand washing facilities in the front display area where employees  display, weigh, and pack fresh fish.

b. The bathroom door is constructed of a non-cleanable wood material.

In addition to the above, we have the following comments.

Your HACCP plans for RTE Seafood Products, and Scombrotoxin Species, do not list verification frequencies that have been developed to ensure that the HACCP plan is adequate to control food safety hazards, and is being effectively implemented to comply with 21 CFR 123.6(c)(6) [FDA-483 Observation #8].  For example:

> The plan for RTE Seafood Products, does not list a verification frequency at  the receiving CCP for checking the accuracy of infrared thermometers used to monitor receiving temperatures of pasteurized, canned crabmeat.

> The plan for Scombrotoxin Species, does not list a verification frequency at the receiving CCP for checking the accuracy of the (b)(4)  thermometers, which are often knocked to the ground by pallet jacks.

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)(1).  However, your firm did not reassess your HACCP plans to adequately control their identified hazards [FDA-483 Observation #10].

Further, to comply with 21 CFR 123.8(a)(2)(ii), you must calibrate process monitoring instruments on an established basis, and document this calibration to comply with 21 CFR 123.8(d) [FDA-483 Observations #7 & #9, respectively].

We have received your letter, dated October 31, 2012, in response to the FDA-483.  Your response does not adequately address each significant observations noted in the FDA-483.  However, we have reviewed your revised HACCP plan, and have the following comments.

Revised HACCP plan for Histamine Fish:

> The plan does not include a corrective action plan with a reference to a critical temperature at the receiving critical control point.  In addition to rejecting the product, the revised plan fails to indicate notification to the supplier of the receiving specifications and the discontinuance of services until evidence proves transportation practices improve.

> The plan does not explicitly indicate at the storage critical control point, the disposition of products exceeding (b)(4) for (b)(4) as a corrective action.

> The plan fails to indicate under records, the number of histamine fish containers examined vs. number of containers in the shipment/cooler at the receiving critical control point.

> The plan fails to indicate under verification, the frequency of the (b)(4) internal temperature checks at the receiving critical control point. Also, the plan does not require an accuracy check before use, or annual calibration.  Further, the plan does not  indicate review of monitoring, corrective action and verification records.

Revised HACCP plan for Pasteurized Crabmeat:

> At the receiving critical control point, the plan indicates under monitoring, that “the logistic record from carrier is required, if available”.  It is crucial to obtain documentation to confirm the transit time of (b)(4).

> At the receiving critical control point, the plan fails to indicate corrective actions for transit time excursions, i.e. (b)(4).

> At the receiving critical control point, the plan fails to indicate the number of crabmeat containers monitored vs. total number of crabmeat containers in the shipment.

> At the receiving critical control point, the plan fails to indicate the discontinuance of supplier services until evidence proves transportation practices improve.

> At the storage critical control point, the plan does not indicate a (b)(4) check of the continuous devices and data with the critical limit.

> At the storage critical control point, the plan does not explicitly indicate as the corrective action the disposition of products with temperatures (b)(4).

> The plan fails to indicate under verification, the review of monitoring, corrective action,  and verification records.

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 an amended HACCP plan 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.

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.

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 Fish and Fishery Products (Seafood Hazard Analysis and Critical Control Point - HACCP) regulation, 21 CFR 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)).  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 Robin M. Rivers, Compliance Officer at the address noted above.  If you have any questions regarding any issues in this letter, please contact Compliance Officer Rivers at 215-717-3076 or e-mail at Robin.Rivers@FDA.HHS.GOV.

Sincerely,

/S/

Kirk D. Sooter
District Director
Philadelphia District

 

Enclosure:
     FDA-483 dated October 11, 2012

 
cc:  Mr. Anthony Grasso, President/Co-owner
       B&A Seafood
       3419 S. Lawrence Street
       Philadelphia, PA  19148-5615

       Mr. Benjamin Venafro, Vice-President/Co-owner
       B&A Seafood
       3419 S. Lawrence Street
       Philadelphia, PA  19148-5615