Inspections, Compliance, Enforcement, and Criminal Investigations
Sysco Food Services of Albany, LLC 03-Jun-2008
Department of Health and Human Services
Public Health Service
New York District
June 3, 2008
RETURN RECEIPT REQUESTED
REF: NYK 2008-14
Gail E. Allen
President & CEO
Sysco Food Services of Albany, LLC
One Liebich Lane
Clifton Park, New York 12065
Dear Ms. Allen:
We inspected your seafood processing facility, located at One Liebich Lane, Clifton Park, New York 12065 on February 11, 13, and 15, 2008. 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 refrigerated, ready-to cat seafood salads and refrigerated, ready-to-eat tuna salads 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.gov.
Your significant violations were as follows:
1. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). However, your firm did not follow the monitoring procedures and frequency of monitoring the ambient temperature of the transport vehicle or, when appropriate, the adequacy of ice or cooling media at the receiving critical control point to control pathogen growth and/or toxin formation as listed in your HACCP plan for your ready-to-eat seafood products. Specifically, your HACCP plan for your ready to-eat seafood products lists monitoring procedures and frequencies at the receiving critical control point for each shipment as either monitoring the [redacted] or visually monitoring the [redacted]. Although monitoring the quantity of ice or cooling media is a procedure listed in your plan, during our inspection, your firm's management stated that none of the refrigerated seafood products are received on ice or other cooling media. Consequently, for your firm to implement the procedures listed in your HACCP plan, all your seafood products should be received with time/temperature recorders (TTRs) for monitoring ambient air temperatures during transport. However, there are Purchase Order Worksheets indicating that you received seafood salad on specific dates without corresponding records associated with the presence of TTRs (i.e., no corresponding [redacted] printouts) on those dates.
Furthermore, review of a monitoring record associated with a TTR collected at receiving for a shipment of refrigerated seafood salad revealed that the time and temperature data on the recorder chart attached to the monitoring record provides no recorded temperatures for approximately the last two days of transport. Specifically, your [redacted] record for the monitoring of ambient temperatures with an end date of 02/03/2008 has a corresponding Purchase Order Worksheet that is signed 02/06/08 and dated 02/05/08. This means that, on the dates between the end of the TTR readings and the dates on the Purchase Order Worksheet, you received shipments of your seafood products but were unable to monitor their ambient air temperatures.
Moreover, several Purchase Order Worksheets indicate that the presence of ice or cooling media is to be confirmed at receiving. Monitoring the presence of ice or cooling media is not an appropriate procedure for receiving your seafood products because these products are not received on ice or cooling media.
2. You must conduct, or have conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have and implement a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(i). A food safety hazard is defined in 21 CFR Part 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plan for ready-to-eat seafood products, which applies to your refrigerated tuna salad, does not list the food safety hazard of scombrotoxin formation for the refrigerated tuna salad.
3. 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). An appropriate corrective action plan must describe the steps to be taken to ensure that no adulterated product enters commerce as a result of a deviation from a critical limit (CL) and that the cause of the deviation is corrected. Your KACCP plan for ready-to-eat seafood products contains a corrective action plan for controlling pathogen growth and/or toxin formation at the storage critical control point that is not appropriate. Specifically, your corrective action plan states "[redacted]" However, your monitoring procedure at the storage critical control point does not involve monitoring product temperature. Thus, it is unclear how your firm will determine which products should be discarded when cooler temperatures exceed the critical limit for more than [redacted]
Moreover, your monitoring frequency for conducting visual checks of storage temperature records, which is listed as [redacted] times per week, means that you will likely not be able to assess the product temperatures within [redacted] of a cooler temperature deviation and/or have an opportunity to adjust the cooler temperature within the specified [redacted] limit.
In addition, this [redacted] time limit associated with a deviation from the temperature critical limit is not defined in that it is not specified as being a cumulative [redacted] limit or a consecutive [redacted] limit.
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: Lillian C. Aveta. If you have questions regarding any issues in this letter, please contact Lillian Aveta at 718-662-5576.
Otto D. Vitillo
cc: Mr. Richard J. Schnieders, CEO
Sysco Food Services
1390 Enclave Pkwy
Houston TX 77077-2099