483
Notrox Research Private LimitedNotrox Research Private Limited – FDA 483
Record Details
Notrox Research Private Limited, a Contract Research Organization in Bangalore, India, received a Form 483 with two observations. The inspection revealed deficiencies in method validation calculations for inter-batch precision and accuracy, as well as inadequate documentation of pharmacokinetic sample handling procedures during a clinical study. These issues indicate concerns with data integrity and adherence to proper study conduct.
- Product type
- drugs
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ID · c57cecfd-20ef-48c1-95d6-1649cb008bb4
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