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  5. M & B Sea Products Inc - 08/26/2014
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WARNING LETTER

M & B Sea Products Inc Aug 26, 2014

M & B Sea Products Inc - 08/26/2014


Recipient:
M & B Sea Products 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 # 437460

UNITED PARCEL SERVICE
OVERNIGHT DELIVERY

August 26, 2014
 

Mr. John F. Murray, President
M & B Sea Products, Inc.
110 Herman Melville Blvd.
New Bedford, MA 02740
 

Dear Mr. Murray:

We inspected your seafood processing facility, located at 110 Herman Melville Blvd., New Bedford, MA on July 28, 2014, July 29, 2014, July 31, 2014, and August 4, 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 (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 refrigerated, reduced oxygen packaged raw, scallops 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 and Controls Guidance, Fourth Edition, through links in FDA's home page at www.fda.gov.

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 plan for ”(b)(4)” lists a critical limit, “(b)(4)”, at the (b)(4) critical control point that is not adequate to control Clostridium botulinum toxin formation.

For refrigerated, reduced oxygen packaged raw, unpreserved scallops, the sole barrier to toxin formation by C. botulinum type E and non-proteolytic types B and F during finished product storage and distribution is refrigeration. These types of C. botulinum will grow at temperatures as low as 38°F (3.3°C). Maintenance of temperatures below 38°F (3.3°C) after the product leaves your control and enters the distribution system cannot normally be ensured. Your firm is not employing the use of a Time-Temperature Indicator (TTI) on the smallest unit of packaging (i.e., the unit of packaging that will not be distributed any further, usually consumer or end-user package) as a means of overcoming these problems in the distribution system.

Your firm’s August 18, 2014 response is inadequate since it did not include a copy of your amended HACCP plan for review or other evidence that your corrective actions have been implemented or include a proposed timetable for full implementation of your proposed corrective actions.

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). However, your firm did not follow the monitoring procedure of visually examining the “(b)(4)” at the (b)(4) critical control point to control Clostridium botulinum toxin formation listed in your HACCP plan for “(b)(4)”.

During our inspection of your operation on July 29, 2014 we observed fresh dry scallops packed in metal cans stored in the walk-in cooler and the packing room. Your firm did not perform the monitoring procedures listed in your HACCP plan and you did not maintain any monitoring records for at least July 28, 2014 and July 29, 2014. A representative of your firm stated that this monitoring did not occur because the Floor Supervisor, who conducts those activities, was unavailable for those days and no responsible alternate was identified to perform the monitoring activities.

Your firm’s August 18, 2014 response is inadequate since it did not include a proposed timetable for full implementation of your proposed corrective actions.

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.

Also, in accordance with 21 CFR 123.10, HACCP plan development, reassessment, modification and record review must be performed by an individual that has completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the U.S. Food and Drug Administration, or who is otherwise qualified through job experience to perform these functions. Your firm does not have anyone trained in seafood HACCP or otherwise qualified through job experience to perform seafood HACCP functions. Your firm’s August 18, 2014 response is inadequate since it did not include a proposed timetable for full implementation of your proposed corrective actions and it does not address how your firm will handle these critical HACCP review activities in the interim.

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 reinspection 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 Shamsi
District Director
New England District
 

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