FDA 483 - MSN LIFE SCIENCES PRIVATE LIMITED - June 30, 2017

MSN Life Sciences Private Limited, an API manufacturer in Shankarampet-R, India, received two observations during an FDA inspection. The observations highlight inadequate laboratory controls, specifically regarding the qualification of GC secondary reference standards and deficiencies in established laboratory control mechanisms. These issues include failures in establishing system precision, assuring sampling medium non-interference, and conducting accuracy studies in cleaning validation.