FDA 483 - MSN LIFE SCIENCES PRIVATE LIMITED - June 30, 2017
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 9e03e6f0-7145-4b0e-9181-f90672f29d09