By: IPP Bureau
Last updated : May 02, 2022 3:00 pm
The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory
The USFDA recently concluded inspection of Shilpa Medicare’s Analytical Services and has made four observations. The site was inspected from April 26-29th 2022.
The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory. The inspection has been closed with four observations, which are related to improvements in existing procedures and are addressable.
The company will be submitting the responses to USFDA observations within the stipulated timeline and implementing the corrective actions to address the observations.
This Analytical Services Division started analytical testing operations from May 2021. This is the first USFDA inspection of this facility. The facility is involved in analytical testing of drug products, drug substances, raw materials & packing materials. It is also engaged in analytical method validations, method transfers and conduct of other miscellaneous studies. This facility has not been used till now to test products for commercial dispatch into US/EU markets.