483
Cdymax (India) Pharma Private LimitedCdymax (India) Pharma Private Limited – FDA 483, May 17, 2019
Record Details
An FDA inspection of Acebright (India) Pharma Private Limited, an API drug manufacturer in Jigani, India, revealed a significant deficiency in laboratory controls. The firm failed to establish scientifically sound test procedures, specifically by not using a second working standard solution during chromatographic analysis to confirm the potency, accuracy, and purity of active pharmaceutical ingredients. This indicates a serious lapse in quality control for their drug products.
View Company Profile
ID · 6bebb67d-1710-4855-b96c-9c78b3cbb505
Other documents for Cdymax (India) Pharma Private Limited
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.