Three products have been exempted from the Import Alert – azacitidine for injection, cyclophosphamide capsules and erlotinib tablets, subject to certain conditions viz. third party certification, no OOSl breach of sterility, triplicate testing and concurrent stability for first three batches. The USFDA exempted formulation sales are the company’s largest revenue source.
The company had received fifteen 483 observations at the close out of FDA inspection on February 25, 2020.
The Warning Letter received on 10 Oct 2020 had specifically mentioned two citations –
(i) inadequate handling of OOS and
(ii) inadequate handling of market complaints, including failure to file FAR within stipulated time.
The company stated, “We had responded to the Warning Letter on October 30, 2020, followed by three follow up responses outlining the CAPAs and their progress.
We have had two tele-meetings with the USFDA on November 12, 2020 and 25 November, 2020. We have not received any subsequent communication from USFDA since November 25, 2020.
This notification of import alert does not mention any further reasons/observations other than nonconformance to cGMP.”
The company further informed, “We have already engaged the services of US-based reputed GMP 3rd Party Consultants to help us with the remediation efforts.
We are committed to addressing the concerns raised by the USFDA and will work with the USFDA to resolve these issues at the earliest.
We uphold quality and compliance with utmost importance and are committed to maintaining cGMP and quality standards across all Shilpa facilities.”
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