FDA 483 - Nicobrand Limited - February 27, 2026

Nicobrand Limited, an API manufacturer in Coleraine County Londonderry, United Kingdom, was cited for significant deficiencies across four observations during an FDA inspection. Key issues include inadequate stability testing methods, insufficient water system monitoring, incomplete process validation, and a systemic failure to thoroughly investigate out-of-specification results and discrepancies. These findings indicate a lack of robust quality control and manufacturing process oversight.