FDA 483 - Wanbury Limited - July 13, 2026

Wanbury, Limited, a non-sterile API manufacturer in Andhra Pradesh, India, was cited for significant deficiencies during an FDA inspection. Observations included issues with process validation, inadequate equipment cleaning and documentation, failure to perform mandatory process steps, and poor accountability for recovered solvents. Additionally, the firm's laboratory records were found to be inaccurate and incomplete, and its microbiological risk management and non-conformance investigation procedures were deemed inadequate.