FDA 483 - APL HEALTHCARE LIMITED - September 19, 2023
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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.
ID · c059bd76-9885-41cc-a930-da938a5760b7