FDA WARNING_LETTER - Orchid Lifesciences - August 08, 2023

The FDA issued a Warning Letter to Orchid Lifesciences, an OTC drug manufacturer in India, following a review of records submitted per a Section 704(a)(4) request. The letter identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to conduct identity testing for components (21 CFR 211.84(d)(1)):** The firm did not adequately test high-risk components like glycerin, propylene glycol, and sorbitol solution for diethylene glycol (DEG) or ethylene glycol (EG) contamination using USP identity tests. This failure poses a significant safety risk due to the lethal potential of DEG/EG contamination. 2. **Inadequate Quality Control Unit (21 CFR 211.22(a)):** The Quality Unit (QU) failed to effectively oversee drug manufacturing operations, specifically in approving or rejecting components in the Materials System. Concerns were raised about potential lack of oversight in other CGMP areas like Production, Facilities & Equipment, Laboratory Controls, and Packaging & Labeling Systems.

The FDA recommends engaging a qualified CGMP consultant to evaluate operations, assist with compliance, and perform a comprehensive six-system audit. The firm was placed on Import Alert 66-40 on March 23, 2023. Corrective actions are required within 30 working days to prevent further regulatory actions