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WARNING LETTER

Empire Crab Company, Inc MARCS-CMS 495889 —


Recipient:
Empire Crab Company, Inc


United States

Issuing Office:
Philadelphia District Office

United States


  

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
16-PHI-06
 
 
VIA UNITED PARCEL SERVICE
 
May 5, 2016
 
 
Mr. Salvatore T. Davis, President
Empire Crab Company, Inc.
3120 S. Galloway Street
Philadelphia, PA 19148-5615
 
Dear Mr. Davis:
 
We inspected your seafood processing facility, located at 3120 S. Galloway Street, Philadelphia, PA, 19148-5615, on March 15 through March 22, 2016. 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 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 pasteurized canned crabmeat is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 (HACCP Guide) through links in FDA's home page at www.fda.gov.
 
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 Pasteurized Canned Crabmeat to control the food safety hazards of Clostridium botulinum and toxin formation.
 
This is a repeat observation from the previous inspections conducted on March 10, 2011 and July 30, 2015, respectively.
 
We have received your undated response including your implemented HACCP plan for Pasteurized Crabmeat. Your response is inadequate, and we offer the following comments. 
 
Receiving Critical Control Point:
 
a.    For the Critical Limits for each Preventive Measure, we recommend you include the critical limits for transit time.  Specifically, the transit time for products that do not exceed 4 hours, as well as the temperature of the product at the time of delivery, to ensure that it does not exceed 40°F for products delivered refrigerated.
 
Monitoring (What will be monitored):
 
b.    Please elaborate to explain, and document how the temperature within the truck or other carrier used throughout transportation is monitored. 
 
c.    We recommend that for products delivered under refrigeration with a transit time of 4 hours or less, you document the date and time the products are picked up, and the date time they arrive at your firm.
 
d.    We recommend that you record the internal temperature of a representative number of product containers at the time of arrival to your firm.
 
Monitoring (How will monitoring be done):
 
e.    For products delivered under refrigeration, we recommend the use of a continuous temperature-recording device for internal product temperature/ambient air temperature of the truck during transit. 
 
f.    For products delivered refrigerated with a transit time of 4 hours of less, we suggest that a review of carrier records be conducted to determine the date and time the product was removed from a controlled temperature environment before shipment, and the date and time delivered.
 
g.    We recommend your firm use a temperature indicating device to determine product temperatures in a representative number of randomly selected containers. A minimum of 12 containers are to be measured unless there are less than 12, in which case all containers should be measured.
 
Monitoring (How often will it be done, frequency):
  
h.    We recommend the frequency should include each lot received.
 
Corrective Actions:
 
i.    Your corrective action should include the discontinuance of the supplier until supplier practices have improved.
 
Verification:
 
j.    The verification should also include accuracy checks for the handheld and/or continuous thermometer.
 
Records:
 
k.    We recommend that you include receiving records showing continuous temperature monitoring and visual check of recorded data, results of internal product temperature monitoring including the number of containers examined and internal temperatures for each.
 
l.    We also suggest that the records include the number of containers in the lot.
 
m.    Your records should include the date and time the product was removed from a controlled environment as well as the date and time the product was delivered.  
 
Cooler Storage Critical Control Point (Corrective Actions):
 
n.    Your corrective actions should include moving some, or all of the affected product from the malfunctioning cooler to another cooler.
 
Verification:
 
o.    We recommend that you include a daily check of the recording device before beginning operations.
 
p.    We suggest you check the data logger for accuracy and damage to ensure that it is operational before putting it into operation, and calibrate it once a year.
 
q.    We recommend that you review monitoring, corrective action, and verification records within one week of preparation.
 
Records:
 
r.    We recommend you conduct a visual check and document recorded data and daily accuracy checks.
 
2.  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 critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” However, your firm’s HACCP plan for Fin Fish (non-histamine species), and Mahi Mahi, Tuna, Wahoo (histamine species) does not list the critical control point(s) of weight, pack and label steps for controlling the food safety hazard(s) of allergens. 
 
This is a repeat observation from the previous inspection conducted on July 30, 2015.
 
Your response fails to report any corrective action taken or planned with respect to this observation.
 
3.  You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with Current Good Manufacturing Practice (CGMP) requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm failed to comply as evidenced by the following:
 
a.    Prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces during processing operations. Specifically, on March 15, 2016, our investigators observed a hose that connects to the facility’s water supply submerged in a trash can filled with water next to a cutting station in the processing room where fluke, halibut, monkfish, and dover sole were being processed. 
 
Your response fails to report any corrective action taken or planned with respect to this observation.
 
In addition, 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). Specifically, on March 15, 2016, our investigators reviewed your Daily Sanitation Records, dated, January 29, 2016; February 12, 2016, and March 3, 2016. All of which were unsigned and undated. However, on March 16, 2016, when our investigators returned to your facility, they noted these same records were signed and back-dated to demonstrate review. Sanitation control records must be maintained, and the information must be documented on the record at the time the activity was observed.  
 
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 an updated HACCP plan, 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)). 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/ 
Anne E. Johnson
District Director
Philadelphia District Office
  
 
cc: Pennsylvania State Department of Agriculture
       Bureau of Food Safety and Laboratory Services
       2301 North Cameron Street
       Harrisburg, PA 17110-9408
       Attention: Dr. Lydia Johnson, Director
 

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