FDA 483 - Startech Labs Private Limited - August 09, 2017

Startech Labs Private Limited, a contracted control testing laboratory in Hyderabad, India, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate employee qualification and training for drug substance testing using Atomic Absorption Spectrophotometer (AAS), as well as a lack of scientifically sound and validated laboratory control procedures for these tests. These issues led to concerns about the reliability of reported drug substance test results.