Recipient NameMr. Frank D. Fogliano
- Fair Fish Co., Inc.
800 Food Center Dr. Unit # 21
Bronx, NY 10474-0015
- Issuing Office:
- New York District Office
UNITED PARCEL SERVICE
May 31, 2018
Mr. Frank D. Fogliano, President
Fair Fish Co., Inc.
800 Food Center Dr. Unit # 21
Bronx, NY 10474-0015
Dear Mr. Fogliano:
The United States Food and Drug Administration (FDA) inspected your seafood processing and distribution establishment located at 800 Food Center Dr. Unit # 21 Bronx, NY 10474, on February 27 and 28, 2018 and March 8, 2018. During the inspection, our FDA investigator observed 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).
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, pasteurized canned crabmeat is adulterated, in that it has been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov.
We acknowledge receipt of your electronic response, dated March 23, 2018 responding to the Form FDA 483, Inspection Observations (FDA 483), issued to you on March 8, 2018. We address the adequacy of specific corrective actions below.
Your significant deviations are as follows:
1. 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 C. botulinum toxin formation when your process for pasteurized canned crabmeat deviated from your HACCP plan's critical limit at the receiving critical control point (CCP). Specifically, the receiving CCP listed in your HACCP plan states (b)(4) or (b)(4) However, a review of your firm's pasteurized canned crabmeat receiving monitoring records for the date of December 4, 2017 revealed that your firm deviated from your critical limit without taking a corrective action that ensured the safety of the product was evaluated, affected product did not enter interstate commerce and that your firm had regained control over the operation.
For example, on December 4, 2017, the time/temperature indicator record showed that the ambient temperature of the trailer exceeded your critical limit of (b)(4) for approximately 33 hours with a high temperature mark of approximately (b)(4). In addition, the product was not covered with ice or other chemical cooling media. Your firm received the shipment of pasteurized crabmeat without conducting a time/temperature assessment and without conducting a corrective action. The product was later distributed into commerce.
We have reviewed your electronic response letter dated March 23, 2018. We acknowledge that your firm has revised your HACCP Plan for pasteurized canned crabmeat. However, your response is inadequate because your firm has not conducted a time/temperature assessment of the effected lots of pasteurized canned crabmeat received on December 4, 2017 that exceeded your critical limit. Further, your response does not indicate an assessment will be conducted of other lots of product. Finally, your response does not include actions your firm will take to prevent recurrence.
2. You must have a HACCP plan that at a minimum lists the critical limits that must be met, to comply with 21 CFR123.6 (c)(3). A critical limit is defined in 21 CFR123.3 (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, our firm's HACCP plan for pasteurized canned crabmeat lists a critical limit of temperature (b)(4) at the receiving and refrigerated storage CCPs that is not adequate to control C. botulinum toxin formation.
FDA recommends that strict refrigeration control (i.e., at or below 40°F (4.4°C)) should be maintained during storage and distribution to prevent growth and toxin formation by C. botulinum type A and proteolytic types B and F. FDA also recommends a maximum cumulative exposure time of 2 hours at a product temperature of above 70°F in order to control germination, growth, and toxin formation by C. botulinum type A and proteolytic types B and F. Your revised HACCP plan's critical limit allows for the product temperature to be above 70°F for up to (b)(4) during transit and up to an additional (b)(4) during refrigerated storage without requiring a corrective action to be taken. This exceeds a cumulative exposure time of 2 hours at a temperature of above 70°F and is not adequate to control C. botulinum toxin formation.
We acknowledge that your electronic response letter dated March 23, 2018 included a revised pasteurized canned crabmeat HACCP plan dated March 19, 2018 however the response is inadequate.Your revised HACCP plan lists a critical limit (b)(4) at the receiving and at the refrigerated storage CCPs that is not adequate to control the significant hazard of C. botulinum.
3. Because you chose to include corrective actions in your HACCP plans, your described corrective actions must be appropriate to comply with 21 CFR123.7(b). However, your corrective action plan listed in your pasteurized canned crabmeat HACCP plan at the receiving and refrigerated storage CCPs are not appropriate as they do not ensure the cause of the deviation is corrected as required by 21 CFR123.7(b)(2).
Specifically, your corrective action is inadequate as it does not state how your firm will regain control of the operation after a critical limit deviation has occurred at the receiving CCP. FDA recommends this corrective action include discontinuing use of the carrier until evidence is obtained that transportation and handling practices have been improved.
We acknowledge within your firm's response that you state that your corrective action for the receiving CCP will include rejecting product and returning the product to sender. However, your revised pasteurized canned crabmeat HACCP plan dated March 19, 2018 does not include notification of rejection or returning the product to the sender. Further it is not only important to notify the supplier of the deviation but also to discontinue the use of the supplier until evidence is obtained that transportation and handling practices have been improved. Your revised pasteurized canned crabmeat HACCP plan does not ensure the cause of the deviation is corrected at the receiving CCP and refrigerated storage CCP.
4. You must review critical control point monitoring records within one week after the records are made, to ensure compliance with 21 CFR 123.8(a)(3). Specifically, receiving CCP monitoring records for canned crabmeat for the time period of September 21, 2017 to February 2, 2018 were not reviewed, signed and dated within one week of the record being made.
We acknowledge your response dated March 23, 2018 which states additional employees will be trained and HACCP certified in order to perform monitoring and corrective action activities; however, your response is inadequate. Your response does not include supporting evidence that additional employees have received seafood HACCP training or the interim action you plan to implement. In addition, you have not indicated that all monitoring records are receiving a verification review by a trained individual in accordance with 21 CFR 123.10.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction.
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 reinspection 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 notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including photographs or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Please send reply to the Food and Drug Administration, Attention: Scott R. Izyk, Compliance Officer, One Winners Circle, Suite 110, Albany, NY 12205. If you have questions regarding any issues in this letter, Please contact Scott R. Izyk at 518-453-2314 x1012 or firstname.lastname@example.org.
Ronald M. Pace
Program Division Director
Office of Human and animal Food Operations East - Division 1