FDA 483 - Mylan Laboratories Limited - May 15, 2026

An FDA inspection of Mylan Laboratories Limited in Sinnar, India, revealed critical deficiencies in data integrity, quality control, and manufacturing practices. The firm was cited for altering manufacturing records, destroying balance printouts, lacking raw data for QC testing, and failing to adequately control analytical balances. Additionally, the inspection found inadequate investigations into out-of-specification results, poor equipment maintenance, non-compliance with stability testing, and failure to submit a required Field Alert Report after a plant fire.