FDA 483 - APL HEALTHCARE LIMITED - September 19, 2023

APL HEALTHCARE LIMITED, a finished dosage drug manufacturer in Nellore, India, was cited for significant failures in its quality control system during an FDA inspection from September 13-19, 2023. The firm failed to thoroughly review discrepancies and ensure scientifically justified conclusions for non-conformance investigations. This included issues with widening specifications without justification, inadequate production record-keeping, and a lack of investigations into recurring laboratory non-conformances.