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

Source: https://www.globalkeysolutions.net/records/warning_letter/gaea-products-sa/ace9f391-6a82-4a5c-bd0b-5a420208ca19

> FDA WARNING_LETTER for Gaea Products S.A. on January 09, 2015. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Gaea Products S.A.
- Inspection Date: 2015-01-09
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: 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

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.globalkeysolutions.net/companies/gaea-products-sa/aebaaacf-f2a8-4f44-9258-586a498b3e77

Office: https://www.globalkeysolutions.net/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2