FDA WARNING_LETTER - Tyche Industries Ltd. - August 16, 2024

The FDA inspected Tyche Industries Ltd. in Kakinada, India, from August 12-16, 2024, identifying significant Current Good Manufacturing Practice (CGMP) deviations for active pharmaceutical ingredients (APIs), rendering their APIs adulterated.

Key violations include: 1. **Failure to record quality-related activities at the time performed:** Management admitted to falsifying temperature data for a drying oven, and employees admitted to preparing a "backdated calculation sheet." The firm's response, proposing a consultant by June 30, 2025, and removing some employees without fully evaluating the scope of data integrity lapses, was deemed inadequate. 2. **Failure to clean equipment and utensils:** Rust-like residues and bare footprints were found inside "cleaned" and "ready for use" non-dedicated equipment. The firm's response, lacking details on review methodology and adequate prevention for personnel entering equipment, was inadequate. 3. **Failure to test identity of incoming production material:** The firm did not test the identity of a raw material ((b)(4)) used in API production. The response, stating "initiated the activity" for (b)(4) but not addressing other raw materials or recurrence prevention, was inadequate.

The FDA cited the firm's quality unit for not fully exercising its authority and responsibilities. The FDA strongly recommended retaining a qualified consultant for data integrity remediation. As a result, products from