Date: May 17, 2025
Location: Mumbai
Cipla Limited has received an update from the United States Food and Drug Administration (USFDA) regarding its recent inspection at the analytical testing facility of Sitec Labs Limited, a wholly owned subsidiary of the company.
The inspection was conducted at the Mahape, Navi Mumbai facility between February 18 and 20, 2025.
In an email communication dated May 16, 2025 (11:57 PM IST), the USFDA has classified the outcome of this inspection as Voluntary Action Indicated (VAI).
What Does VAI Mean?
- A VAI classification implies that objectionable conditions were found, but no formal regulatory action is expected.
- The facility is not subject to a warning letter or import alert.
- The company is expected to address and correct the observations voluntarily.
Background
- The company had earlier disclosed the inspection on February 20, 2025, under SEBI disclosure norms.
- The facility is dedicated to analytical testing and plays a role in quality control processes.
Company Statement
Cipla has confirmed the receipt of the VAI classification and has informed the stock exchanges and the Luxembourg listing authority.
Investors and stakeholders are advised to consider this development in the context of ongoing regulatory compliance at Cipla’s group companies.