FDA WARNING_LETTER - Gaea Products S.A. - January 09, 2015

The FDA inspected GAEA Products S.A.'s acidified food (AF) processing facility in Agrinio, Greece, on January 8-9, 2015, identifying serious violations of 21 CFR Parts 108 and 114. The firm's responses dated January 30 and March 6, 2015, were deemed inadequate.

Key violations include: 1. **Failure to process Santorini Cooking Sauce according to the filed scheduled process (SID (b)(4))**: The firm's operating process parameters for initial temperature, process time, and maximum equilibrium pH differed from the filed process. Submitted documentation, including a HACCP study and a university validation, contained only literature references and lacked supporting thermal process data. A revised scheduled process filing has not been submitted to the FDA. (21 CFR 108.25(c)(3)(i)) 2. **Failure to maintain processing records showing adherence to scheduled processes**: Specifically, the initial temperature (IT) was not measured during the processing of Santorini Cooking Sauce. (21 CFR 114.100(b)) 3. **Operators of processing and packaging systems not supervised by a Better Process Control School (BPCS) certified person**: The firm's response that supervisors have university degrees in food processing and will attend an ad hoc course does not satisfy the BPCS requirement. (21 CFR 1