FDA 483 - Dr Reddy's Laboratories Limited - January 15, 2019

The FDA Form 483 details observations from an inspection, highlighting several deficiencies in quality control and manufacturing processes.

**Key Violations and Observations:**

* **Inadequate Investigations:** * Failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results for stability batches, specifically regarding API impurity levels. * Investigation OOS 310013508 for OOS tablet results was not thorough, failing to confirm the use of tubes as a root cause and not evaluating why a concurrently prepared sample from another lot did not detect the impurity. * Retesting after invalidating OOS results was performed on a single sample rather than the required number per SOP GQA035. * Investigation of complaint 200217023 for a released batch did not extend to other distributed batches of the same product or include analytical testing of returned or reserve samples. * Investigation OOS 310013534 for an OOS tablet assay did not expand to include prior batches, despite hypotheses of analyst error or inappropriate sampling.

* **Data Integrity and Computer Controls:** * Inadequate controls over computer systems to ensure changes to master records are made only by authorized personnel. * Instrument PR186, used for in-process testing, uses a common password, allows operators to change time/date,