SHILPA MEDICARE LIMITED Shilpa Medicare Limited informed that the US FDA GMP inspection performed on Company's Analytical Services Division situated on first Floor of Unit 7, Nacharam, Hyderabad, Telangana, has been cleared with a status of `voluntary action indicated (VAI)'. The inspection was held during 08 March 2023 to 10 March 2023, with issuance of 2 observations. The VAI inspection classification indicates that the US FDA will not take or recommend regulatory or enforcement action because the observations do not meet the threshold for action at this time.
The company is committed to ensure continued compliance with cGMP's. This is the second US FDA GMP inspection of this facility within one year. The facility is identified as testing laboratory in numerous ANDAs filed by the company and its agreed parties. 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 analytical studies. This facility has started the testing of US/EU & other markets commercial batches.
