# FDA WARNING_LETTER - third synthesis inc.,  - March 24, 2022

Source: https://www.keypedia.com/records/warning_letter/third-synthesis-inc/0851faf4-ad0f-4d7f-93be-7e7107393ae1

> FDA WARNING_LETTER for third synthesis inc.,  on March 24, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: third synthesis inc., 
- Inspection Date: 2022-03-24
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: The FDA inspected a bakery facility at 5569 N. Northwest Highway, Chicago, IL, from February 24 to March 24, 2022, with a follow-up on May 3, 2022. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), leading to the determination that ready-to-eat (RTE) cakes and paczkis were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include:
1.  **Inadequate Hazard Analysis and Preventive Controls (21 CFR Part 117, Subpart C):**
    *   Failure to appropriately evaluate undeclared allergens as a significant hazard requiring preventive controls, despite a recall on February 25, 2022, for undeclared wheat, milk, and/or egg in paczkis and coffee cakes. The allergen control program lacked adequate monitoring frequency and implementation.
    *   Failure to adequately control allergen cross-contact. The hazard analysis incorrectly determined allergen cross-contact did not require a preventive control based on the Sanitation SOP. The allergen control program was insufficient, lacking monitoring/verification and not addressing all food-contact equipment or distinguishing between products with different allergen profiles. Observations included cross-

## Related Officers

- [Program Director](https://www.keypedia.com/people/william-r-weissinger/4b648d9e-90cc-48e9-9bac-f782bed02d89)

Company: https://www.keypedia.com/companies/third-synthesis-inc/f3c75f5b-12df-4a21-9326-697f26fbafb1

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766