The inspection closed with 2 minor observations, which are related to improvements in existing procedures and are addressable.
This is the second US FDA inspection on the site. The initial inspection was done during April 2022, for which the GMP clearance (EIR) was issued in July 2022.
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 is involved in the testing of US/EU & other markets commercial batches.
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