| Public Health Service Food and Drug Administration |
| College Park, MD |
Department of Health and Human ServicesSep 28 2010
WARNING LETTER
VIA OVERNIGHT MAIL
Mr. Gerald St. Jean
President
St. Jeans Cannery Ltd.
252 Southside Dr.
Nanaimo BC
Canada
Reference No.: 132931
Dear Mr. St. Jean:
FDA inspected your low-acid canned food facility, St. Jeans Cannery Ltd.., located at 252 Southside Dr., Nanaimo Be, Canada, on July 19-21, 2010. During that inspection, we found that your firm had serious deviations from the low-acid canned food (LACF) regulations, Title 21 Code of Federal Regulations, Parts 108 and 113 (21 CFR Parts 108 and 113). Failure to comply with all of the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113 constitutes a basis for the immediate application of the emergency permit control provisions of Section 404 of the Act, particularly implementation of 21 CFR 108.35(k) for products offered for entry into the United States. In addition, such failure renders your LACF 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 product, canned sockeye salmon, is adulterated in that the product has been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. You can find the Act and the low-acid canned food regulations through links in FDA's home page at http://www.fda.gov.
At the conclusion of that inspection, our investigator issued a FDA Form 483, a form listing the observations of concern noted during the inspection. Your significant violation is the following:
• During retort operation on 7/20/10, the retort operator was observed to partially close the retort bleeder valves located on top of the retort and on the thermometer well. The bleeders remained partially closed during the cook cycle. Bleeders shall be wide open during the entire process as required by 21 CFR 113.40(a)(8).
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.
You should include in your response documentation such as any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within thirty days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported LACF products under Section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the canned food regulations (21 CFR Part 108 and 113) is Import Alert #99-04. This alert can be found on FDA's web site at: http://www.fda.gov/ora/fiars/ora_import_ia99-04.html .
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 and all applicable regulations including the low-acid canned food regulations ((21 CFR Parts 108 and 113) 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U. S. Food and Drug Administration, Attention: Donald W Greaves, 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 Mr Greaves at (301) 436-2057 or via email at dgreaves@cfsan.fda.gov.
Sincerely,
/S/
Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
No comments:
Post a Comment