DEPARTMENT OF HEALTH & HUMAN SERVICES
VIA EXPRESS MAIL
Mr. Terry Earnshaw, Technical Manager
Simpson Ready Foods Ltd.
Stretford Road, Urmston
Manchester, M41 9WH, United Kingdom
Reference No.: 259675
Dear Mr. Earnshaw:
The U.S. Food and Drug Administration (FDA) inspected your food facility located at Stretford Road, Urmston, Manchester, M41 9WH, United Kingdom on September 5-6, 2011. At this facility, you manufacture low-acid canned food products, namely puddings and sauces.
As a manufacturer of low-acid canned food products, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of low-acid canned food products that you export to the United States. These regulations are described in Title 21, Code of Federal Regulations, Part 108, Emergency Permit Control (21 CFR 108) and Part 113, Low-Acid Canned Foods (21 CFR 113). As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.35(k), for imported products, in lieu of issuing an order of determination that a permit is required before products from such commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor’s products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. In addition, violation of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR Part 113 renders your low-acid canned food products adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)]. You can find the Act and the low-acid canned food regulations through links in FDA’s home page at http://www.fda.gov.
This inspection resulted in FDA’s issuance of an FDA-483, Inspectional Observations, at the conclusion of the inspection which listed the deviations found at your firm. Your firm provided no response to the FDA-483; therefore, we have the following remaining concerns with regard to your low-acid canned food products:
Your firm failed to determine and record the initial temperature of the contents of the containers to be processed to ensure that the temperature of the product is no lower than the minimum initial temperature specified in the scheduled process as required by 21 CFR 113.87(c). Specifically, our investigator observed your firm’s employees not measuring the initial temperature of product while manufacturing Simpsons Chocolate Sponge Pudding b(4). Although this product was not being manufactured for shipment to the United States at the time of the inspection, you informed the investigator that this test is not performed at all.
Your firm failed to measure and record critical factors specified in the scheduled process to ensure that the factors are within the limits specified in the scheduled process as required by 21 CFR 113.40(a)(13). Specifically:
Our investigator observed your firm’s employees not performing the test for the critical factor of b(4) while manufacturing Simpsons Chocolate Sponge Pudding b(4)
- Our investigator observed your firm’s employees not b(4) testing of finished product when b(4) is listed as a critical factor in your scheduled process for Simpsons Chocolate Sponge Pudding b(4)
Although this product was not being manufactured for shipment to the United States at the time of the inspection, you informed the investigator that this test is not performed at all.
- Your firm failed to record observations made during visual examinations of container closures as required by 21 CFR 113.60(a). Specifically, your firm does not record the observations made during visual closure examinations of the plastic containers and heat-sealed lids in which the Simpsons Chocolate Sponge Pudding is packed.
You should respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty (30) days, 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 you firm operates in compliance with the Act, the low-acid canned food regulations (21 CFR Parts 108 and 113), the Current Good Manufacturing Practice regulation (21 CFR Part 110), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Robyn R. Jones, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Manufacturing and Storage Adulteration Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. Jones at (240) 402-2575 or via email at email@example.com.
Jennifer A. Thomas
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition