FDA 483 - Mylan Laboratories Limited - May 17, 2024

Mylan Laboratories Limited, a sterile drug manufacturer in Hosur, India, was cited for significant deficiencies in aseptic processing during an FDA inspection. Observations included inadequate cleaning and disinfection systems, insufficient validation of aseptic processes, and failure to investigate microbiological contamination. The firm also failed to submit a required Field Alert Report for an OOS stability failure and deviated from written test procedures without justification.