FDA 483 - Tyche Industries Ltd. - August 16, 2024

Tyche Industries Ltd. received an FDA Form 483 following an inspection of their API manufacturing facility in Kakinada, India, from August 12 to August 16, 2024. The inspection revealed significant departures from Current Good Manufacturing Practices (CGMP).

Key observations included a failure of the quality unit to ensure CGMP compliance, evidenced by an inadequate investigation into an Out-of-Specification API batch where operators admitted to falsifying drying data, and the use of unapproved, backdated batch record changes. The company also failed to thoroughly investigate and resolve customer complaints, often not identifying root causes for issues like high moisture content and product mix-ups. Analytical test procedures for Active Pharmaceutical Ingredients (APIs) were found to be unvalidated or unverified, impacting products actively supplied to the U.S. market.

Additional issues included inadequate equipment cleaning, with observations of rust and contamination risks in 'cleaned' production vessels, and a deficient employee training program, lacking basic GMP, Good Documentation Practice, and Data Integrity training for new hires, with scheduled refreshers for existing staff also missed. Furthermore, the firm failed to conduct identity testing for critical incoming raw materials, relying solely on supplier certifications, and lacked required Quality Agreements with many Key Starting Material and Critical Raw Material suppliers, contrary to their own written procedures. Tyche Industries Ltd. is required to implement comprehensive corrective and preventive actions to address these systemic compliance issues.