FDA WARNING_LETTER - Lantech Pharmaceuticals Limited - March 15, 2019

The FDA inspected Lantech Pharmaceuticals Limited (FEI 3012390454) in India from March 6-15, 2019, identifying significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Inadequate Investigation into Impurities:** The firm's investigation into N-Nitrosodiethylamine (NDEA) contamination in recovered valsartan solvent was insufficient, demonstrating a lack of understanding of potential risks in their solvent recovery process. 2. **Poor Equipment Cleaning and Maintenance:** No logbooks were maintained for non-dedicated storage, receiving, and solvent recovery tanks. Unknown material and residue were observed in tanks, and cleaning frequencies lacked scientific justification. Cleaning validation for Lamivudine Coupled Ester (LVC) intermediate production was also inadequate, with no commitment to revalidate. 3. **Failure to Control Impurity Risks:** The firm lacked procedures to evaluate and control impurity risks in solvent recovery, including adequate testing, impurity profiling, and monitoring. They also failed to investigate unknown peaks in recovered solvent chromatograms. 4. **Compromised Data Integrity:** The Senior General Manager of Quality, also the Administrator for chromatographic data systems, had full access privileges, including data editing/deletion. The firm admitted to routinely deleting recovered solvent gas chromatography (GC) data older than three months without backup. Hard copies