FDA 483 - Terrain Pharmaceuticals - August 02, 2019

Terrain Pharmaceuticals in Reno, NV, was inspected and received a Form 483 with four observations. The inspection revealed significant issues including a failure to investigate out-of-specification stability results, inadequate statistical quality control criteria and method validation, deficiencies in batch production and control records related to labeling, and insufficient GMP training for employees. These findings indicate a lack of robust quality systems and oversight in critical manufacturing and quality control processes.