FDA 483 - Mylan Laboratories Limited - June 26, 2024

Mylan Laboratories Limited in Pithampur, India, received a Form 483 citing significant deficiencies across multiple quality systems during an inspection from June 14-26, 2024. Key issues include inadequate equipment cleaning leading to potential cross-contamination, scientifically unsound out-of-specification investigations, deficient laboratory controls and test procedures, and concerns regarding data integrity and computer system controls. The findings indicate a broad breakdown in GMP compliance, posing risks to drug product quality and purity.