FDA 483 - Macleods Pharmaceuticals Limited - November 01, 2021

An FDA inspection of Macleods Pharmaceuticals Limited, a drug product manufacturer in District Solan, India, revealed significant Good Manufacturing Practice deficiencies. Repeated observations included inadequate equipment cleaning procedures leading to drug product residue and potential cross-contamination, and deficient Out-of-Specification investigations lacking scientific rationale. Other findings involved unvalidated cleaning processes, insufficient risk assessments for impurities, failed process performance qualifications, poor computer system controls, and facility maintenance issues.