FDA 483 - Bal Pharma Limited- Unit 2 - November 16, 2018

Bal Pharma Limited, a manufacturer in Bangalore, India, was inspected and cited for significant deficiencies across its quality control and production processes. Observations included a lack of scientific justification for intermediate retest dates, failure to follow quality unit procedures for record documentation, inadequate evaluation of packaging material suppliers, and missing label specimens in batch records. The inspection revealed systemic issues in maintaining proper controls and documentation for manufacturing and packaging materials.