By: IPP Bureau
Last updated : June 27, 2024 12:38 pm
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies
The Bio Analytical Laboratory, Shilpa Medicare Limited, Unit 7, Nacharam, Hyderabad, India was inspected by USFDA from 26th February to 1st March 2024. The inspection was concluded with zero 483 observations and no discussion items.
The Agency has concluded that this inspection has now been closed with the issuance of the Establishment Inspection Report (EIR). The facility is classified as "No Action Indicated" (NAI).
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies and BA/BE studies in human subjects as per global regulatory requirements. This is a newly set up Centre for bio-analytical testing and this is the first regulatory inspection and approval for this Site from USFDA.
This facility is approved by EMA, Europe.xxxxx