FDA WARNING_LETTER - Lactasoy Company Limited - November 04, 2009

The FDA inspected a low-acid canned food facility in Prachinburi, Thailand, on November 3-4, 2009, and found serious deviations from low-acid canned food regulations (21 CFR Parts 108 and 113). These failures render the firm's soymilk in glass bottles adulterated under Section 402(a)(4) of the Act. Significant violations included the retort lacking an accurate temperature recording device (21 CFR 113.40(D)(2)), absence of a product traffic control system in the retort room (21 CFR 113.87(b)), failure to measure cold water vacuum for glass containers (21 CFR 113.60(a)(2)), and not providing scheduled process information with critical control factors for soymilk (21 CFR 108.35(c)(2)). The firm must respond in writing within thirty working days, outlining specific corrections and providing documentation. Failure to adequately respond may lead to further action, including refusal of admission for imported products under Section 801(a) and detention without physical examination (DWPE), potentially through Import Alert #99-04.