FDA 483 - Hikal Limited - February 07, 2025

Hikal Limited, an API and intermediate manufacturer in Jigani, Bengaluru, was cited for significant quality system deficiencies during an FDA inspection. Observations include inadequate investigation of foreign matter complaints, routine invalidation of Out-Of-Specification (OOS) results without justification, and failures in critical equipment maintenance. Additionally, the firm's vendor qualification procedures are deficient, backup data lacks proper protection, and computerized system incidents are not recorded or investigated.