FDA 483 - Macleods Pharmaceuticals Limited - October 20, 2023

Macleods Pharmaceuticals Limited, a non-sterile drug manufacturer in Baddi, India, was cited for multiple significant deficiencies during an FDA inspection. Repeat observations included inadequate cleaning procedures and insufficient computer system controls. The firm also failed to ensure proper stability testing, quality control review of records, and timely Field Alert Report submission, indicating a broad range of quality system issues.