FDA 483 - Mylan Laboratories Limited - May 17, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 73aaabc3-28a1-4b68-9271-32eb560ddc2c