FDA 483 - Granules India Limited - June 20, 2025
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Granules India Limited, an API manufacturer in Sangareddy District, Telangana, India, was cited for significant failures in documenting and investigating deviations from established procedures. Observations included the approval of a Quality Comparison Report with an incorrect drug name that went uninvestigated for an extended period, and uninvestigated out-of-specification differential pressure readings in a cleanroom corridor. These issues highlight deficiencies in the firm's quality system and deviation management.
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