FDA WARNING_LETTER - St. Jeans Cannery Ltd. - July 21, 2010

On July 19-21, 2010, the FDA inspected St. Jeans Cannery Ltd. in Nanaimo, BC, Canada, a low-acid canned food (LACF) facility. The inspection revealed serious deviations from LACF regulations (21 CFR Parts 108 and 113), rendering products like canned sockeye salmon adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

A significant violation noted on FDA Form 483 was the retort operator partially closing retort bleeder valves during a cook cycle on July 20, 2010. This violates 21 CFR 113.40(a)(8), which requires bleeders to be wide open throughout the process.

The company must respond in writing within thirty working days, outlining specific corrective actions and providing supporting documentation. Failure to respond adequately may lead to further action, including refusal of admission for imported LACF products under Section 801(a) of the Act, potentially through detention without physical examination (DWPE) as per Import Alert #99-04. The letter emphasizes the firm's responsibility to comply with all applicable regulations, including 21 CFR Parts 108, 113, and 110.