483
Aurobindo Pharma LimitedFDA 483 - Aurobindo Pharma Limited - September 27, 2019
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Record Details
Aurobindo Pharma Limited, a finished product manufacturer in Polepally, India, was cited for significant deficiencies across its quality system. Observations included failures in out-of-specification (OOS) investigations, lack of adequate written procedures for production and process controls, and incomplete laboratory records. These issues indicate a systemic breakdown in ensuring drug product quality, identity, strength, and purity.
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