FDA 483 - Dr. Reddy's Laboratories Limited - February 21, 2017

This FDA Form 483 document details observations from an inspection, primarily concerning deficiencies in test method validation, instrument calibration, and adherence to established test methods for Active Pharmaceutical Ingredients (APIs) and raw materials.

**Violations and Observations:**

1. **Specificity of Test Methods Not Established:** * **HPLC Optical Purity Test (Validation 20-06/66/2002):** The firm failed to perform stress (forced degradation) studies during validation for the USP non-compendial optical purity test by HPLC. The validation lacked necessary specificity/selectivity studies. The current HPLC chromatographic purity profile differed from validation, with the main peak retention time changing. * **Related Substances Analytical Test Method (Validation 20-AVR-001-10):** Validation for this non-compendial method lacked specificity/selectivity studies to determine if it was stability-indicating. Complete forced degradation studies were not performed, and degradation of the main peak was not achieved. The routine analytical test method specification (S-08-USP/07) also failed to include precision standard system suitability (%RSD) for sample solution injection. Despite these issues, the validations were approved by QCU.

2. **Deficient Instrument Calibration Procedures/Practices:** * **Gas Chromatographic (GC) Instruments (Agilent GC/Headspace QC-206):**