Inspections, Compliance, Enforcement, and Criminal Investigations

Intershell International Corp. 9/26/14

  

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 # 440205 
                                                                                                           
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
 
September 26, 2014
 
 
Ms. Yibing-Gau Rome, President
Intershell International Corp.
9 Blackburn Drive
Gloucester, MA 01930-2237
                       
                                                                       
Dear Ms. Rome:
 
We inspected your seafood processing facility, located at 9 Blackburn Drive, Gloucester, MA on August 22, 2014, August 25, 2014, and August 29, 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 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 and Controls Guidance, Fourth Edition, through links in FDA's home page at www.fda.gov.
 
We acknowledge the receipt of your firm’s email, dated September 9, 2014, in response to the form FDA 483, Inspectional Observations, issued during the inspection of your firm on August 29, 2014. We address this response below, in relation to the noted violations.
 
Your significant violations were as follows:
 
1.    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 pasteurized canned crabmeat does not list the critical control point of receiving for controlling the food safety hazard of Clostridium botulinum toxin formation.
 
During our inspection we found that your company owned refrigerated trucks used to pick up ready to eat pasteurized canned crabmeat from your suppliers are not continuously monitored to ensure adequate temperatures and the product is not covered in ice during transport. Your firm does not determine and record the internal product temperatures in a representative number of product containers randomly selected from throughout the shipment, at delivery. Also, your firm does not review transport records to determine the date and time the product was removed from a controlled temperature environment before shipment and you do not record the date and time at delivery.
 
Your firm’s September 9, 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 and you did not include a proposed timetable for full implementation of your proposed corrective actions.
 
2.    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 pasteurized canned crabmeatlists a critical limit at the “ (b)(4)” critical control point of “(b)(4)” that is not adequate for controlling the food safety hazard of Clostridium botulinum toxin formation.
 
For refrigerated pasteurized canned crabmeat, 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 Clostridium botulinum type A and proteolytic types B and F.
 
Your firm’s September 9, 2014 response indicates that you have changed your critical limit at the (b)(4) critical control point to(b)(4). However we find your response is not adequate since you did not include a copy of your amended HACCP plan for review or other evidence, such as monitoring and verification records, which demonstrate that your corrective actions have been implemented. Additionally, your response does not include a proposed timetable for full implementation of your proposed corrective actions.
 
3.    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 (b)(4) at the (b)(4) critical control point for controlling the food safety hazard of Clostridium botulinum toxin formation listed in your HACCP plan for refrigerated pasteurized canned crabmeat.
 
During our inspection of your operation we observed you do not use a continuous temperature monitoring device to monitor the cooler temperature and continuous temperature monitoring documentation could not be provided for review.
 
Your firm’s September 9, 2014 indicates that you intend to install a continuous monitoring device.  However, we find your response is not adequate since you did not include any evidence, such as monitoring and verification records, which demonstrate that your corrective action has been implemented and you did not include a proposed timetable for full implementation of your proposed corrective action. Further, you did not indicate what refrigerated storage monitoring measures that you will employ in the interim while you wait for the installation of a continuous monitoring device.
 
4.    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 (b)(4) critical control point to control the food safety hazard of Clostridium botulinum toxin formation listed in your HACCP plan for refrigerated pasteurized canned crabmeat.
 
During our inspection of your operation we observed you do not use a continuous temperature monitoring device to monitor the cooler temperature and continuous temperature monitoring documentation could not be provided for review.
 
Your firm’s September 9, 2014 response is not adequate since it did not include a copy of your amended HACCP plan for review or other evidence that your corrective actions have been implemented and you did not include a proposed timetable for full implementation of your proposed corrective actions. Further your response did not include copies of monitoring and verification records that demonstrate you are implementing the monitoring and verification records required under your HACCP plan.
 
5.    Because you choose 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 firm’s corrective action plan at the (b)(4) critical control point to control the food safety hazard of Clostridium botulinum toxin formation listed in your HACCP plan for refrigerated pasteurized canned crabmeat is not appropriate. Specifically, your corrective action plan does not include procedures to bring affected products back under temperature control or procedures to investigate the root cause of the deviation to ensure control of the process. 
 
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 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 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.
 
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 S. Shamsi
District Director
New England District

Page Last Updated: 02/05/2015
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