FDA WARNING_LETTER - Flavour Makers Pty Ltd - January 09, 2013

An FDA inspection conducted on January 8 and 9, 2013, at Flavour Makers Pty., Ltd.'s acidified sauces processing facility in Australia, revealed significant deviations from 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods). These deviations render the firm's acidified foods adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The primary violation identified was the firm's failure to process its acidified foods in conformity with the scheduled processes filed under 21 CFR 108.25(c)(2), as required by 21 CFR 108.25(c)(3)(i). Specific examples included manufacturing Korma Simmer Sauce at a lower temperature than the filed scheduled process and not adhering to the critical factors of the filed "(b)(4)" thermal processing method for other acidified sauces. The firm was instructed to respond in writing within 15 working days, outlining specific corrective actions, providing documentation such as revised procedures and processing records, and amending any process filings. Failure to adequately respond could lead to further action, including refusal of admission of products into the U.S. under Section 801(a) (Detention Without Physical Examination) and assessment of reinspection fees under Section 743 of the Act.