FDA WARNING_LETTER - Vega Life Sciences Private Limited - November 28, 2019

On June 17, 2020, the FDA issued a Warning Letter to Vega Life Sciences Private Limited following an inspection from November 25-28, 2019, identifying significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API). The facility's API are deemed adulterated.

Key violations include: 1. **Failure to control and monitor solvent recovery procedures:** The firm, acting as a contract solvent recovery facility, failed to establish and follow procedures for evaluating and controlling impurity risks. This involved inadequate testing of recovered solvents (e.g., not using standards for GC analysis of recovered (b)(4) in 2018-2019) and failure to establish impurity profiles or investigate extraneous peaks in chromatograms. The firm released batches with unknown peaks without investigation or informing customers. 2. **Inadequate cleaning procedures:** The firm failed to ensure sufficient cleaning procedures for non-dedicated manufacturing equipment used to recover customer solvents, leading to potential contamination or carry-over. There were no records to document cleaning of non-dedicated equipment. 3. **Insufficient controls over computerized systems and data integrity:** The firm failed to implement adequate controls to ensure data integrity, including missing raw data files, shared usernames/passwords for QC analysts, lack of backup for recovered solvent data, and no procedure governing audit trail retention.

The FDA recommends retaining a qualified consultant for data integrity remediation and