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Jun 27, 2024 · 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.
Jun 25, 2024 · In an official statement, Shilpa Medicare Limited reported that the FDA has issued an Establishment Inspection Report (EIR) and classified the facility under "No Action Indicated" (NAI).
- Asmita Pant
Jun 25, 2024 · 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.
Jun 26, 2024 · 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).
Jun 25, 2024 · In a statement provided by Shilpa Medicare Limited, the FDA stated that it had issued an Establishment Inspection Report (EIR) and classified the facility as “No Action Indicated” (NAI). With this grade, the FDA has concluded that the facility complies with regulations for the duration of the inspection.
May 22, 2023 · 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)'.
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Does Shilpa Medicare have a no action indicated (Nai)?
Is Shilpa Medicare inspected by FDA?
When did Shilpa Medicare close its bio-analytical laboratory?
What is the current status of Shilpa Medicare Limited?
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.
