FDA WARNING_LETTER - Magadoo Corporation Co., Ltd. - August 22, 2017

On October 6, 2017, the FDA issued a Warning Letter to Magadoo Corporation Co., LTD, Thailand, following an inspection on August 21-22, 2017. The inspection revealed serious violations of regulations for Acidified Foods (21 CFR Part 108 and 21 CFR Part 114).

The key violations include: 1. **Failure to file scheduled processes:** The firm did not provide FDA with information on scheduled processes, including conditions for heat processing, pH, salt, sugar, and preservative levels, for acidified food products like Indian Trumpet Fruit Pickle and Fig Pickle, as required by 21 CFR 108.25(c)(2). 2. **Failure to register as an acidified food processor:** The firm was manufacturing, processing, and packaging acidified foods without registering with the FDA using Form FDA 2541 (Food Canning Establishment Registration), as mandated by 21 CFR 108.25(c)(1).

These violations render the firm's acidified food products adulterated under Section 402(a)(4) of the Act. The FDA acknowledged the firm's September 4, 2017, response but deemed it inadequate.

Magadoo Corporation Co., LTD was required to respond in writing within fifteen working days, outlining specific corrective actions, including proof of registration (FCE number)