Inspections, Compliance, Enforcement, and Criminal Investigations
Slade Gorton & Company, Inc. 02-Jun-06
Department of Health and Human Services
Public Health Service
New England District
June 2, 2006
RETURN RECEIPT REQUESTED
Michael Gorton, Sr., Owner
Slade Gorton & Company, Inc.
225 Southampton Street
Boston, MA 02118
Dear Mr. Gorton:
We inspected your seafood processing facility, located at 225 Southampton Street, Boston, Massachusetts on April 10 to 17, 2006. 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 123 & 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 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 various 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 through links in FDA's home page at www.fda.qov.
Your significant violations were as follows:
1. 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 plan for "Fresh/Refrigerated (Chilled), Not Ready-To-Eat, H & G and other Forms (Gutted) of Tuna and Other Scombrotoxin Forming Fish Species" and your firm's HACCP plan for "Smoked Fish, brined or pickled fish, marinated fish, iutefish and similar products (refrigerated)" the following inadequate monitoring procedures and/or frequencies:
A. Specifically for the Fresh/Refrigerated (Chilled), Not Ready-To-Eat, H & G and other Forms (Gutted) of Tuna and Other Scombrotoxin Forming Fish Species HACCP plan:
You list two monitoring procedures, one associated with temperature and the other associated with ice/cooling media at the receiving critical control point (CCP) that are not adequate to control scombrotoxin formation. Specifically,
Your first monitoring procedure at the receiving CCP lists in column #4 that you will monitor [redacted]. However, for fish that are in transit for extended time period prior to delivery (i .e., transit times greater than four hours), this is not adequate because it does not provide any record of temperatures throughout the transit period. We recommend that firms implement a procedure capable of providing a continuous monitoring record of the ambient temperature of the cargo area of the truck or some similar type record that provides a continuous readout of the temperatures.
Your second monitoring procedure at the Receivin CCP lists in column #4 that you will monitor [redacted].However, your critical limits do not correlate to what you are monitoring (i.e., ice and/or gel packs), but are associated with temperatures. Your plan should list that you will visually monitor for the presence of adequate ice and/or monitor the condition of the gel packs.
You list monitoring procedures at the storage critical control point that are not adequate to control scombrotoxin formation because the procedure do not correlate to what you list that you intend to monitor. Your monitoring procedures in column #4 list that you will monitor [redacted] while your critical limits in column #3 list that you will monitor [redacted]. Your critical limits should list that the adequacy of the ice and/or gel pack.
B. Specifically, for the Smoked Fish, brined or pickled fish, marinated fish, lutefish and similar products (refrigerated) HACCP plan, which you represented as including refrigerated, pasteurized crabmeat:
Your monitoring procedures at the receiving CCP lists that you will monitor [redacted].
As mentioned above, for temperature sensitive fish that are in transit for extended time period prior to delivery (i.e., transit times greater than four hours), this is not adequate because it does not provide any record of temperatures throughout the transit period. We recommend that firms implement a procedure capable of providing a continuous monitoring record of the ambient temperature of the cargo area of the truck or some similar type record provides a continuous readout of the temperatures.
When products are in transit for less than four hours, it is appropriate to establish monitoring procedures similar to those you have fisted in your plan (i.e., based on product temperature). However, we note that your plan includes monitoring procedures in column #5, i .e., [redacted] that do not correspond to column #3, where you list that you will monitor [redacted]
You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for pasteurized crabmeat lists a monitoring frequency at the cooler storage critical control point that is not adequate to control pathogen and toxin formation. Your plan lists that you will [redacted] . We recommend recommend implementing a continuous monitoring procedure.
2. 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). However, your corrective action plan at the second receiving CCP associated with monitoring for the presence of s not adequate. Your corrective action indicates that you will 1) [redacted] and 2) [redacted]. However, these actions do not ensure that violative product does not enter commerce.
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.
Please send your reply to the Food and Drug Administration, Attention: Bruce R. Ota, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. Ota at 781-596-7762.
Gail T. Costello
New England District