A visit to Biocon’s Plot 2-4 Phase IV facility in Bangalore, India in May by the US Food and Drug Administration (FDA) ended with a Form 483 with 10 deviations from current good manufacturing practice (cGMP).
But the FDA has issued an Establishment Inspection Reports (EIR) and placed the facility on ‘voluntary action indicated’ (VAI) status, according to a letter filed by Biocon with the Bombay Stock Exchange this week.
“The FDA has classified the outcome of this inspection as VAI and the EIR states that the inspection is closed,” the firm said.
Among other products, Biocon manufactures biosimilar products co-developed with Mylan from the Bangalore site. In August the FDA pushed back the action date on the firms’ Herceptin (trastuzumab) biosimilar by three months, though Biocon told Biopharma-Reporter at the time the target date extension was “linked to the review of the clarificatory information sought as part of the application review process,” and “not related to any cGMP audit observations.”
The facility has also felt regulatory pressure from European regulators. An inspection in March by France’s regulatory body ANSM (Agence Nationale de Sécurité du Médicament) resulted in a statement of non-compliance with GMP being issued to the firm in July, citing 35 issues at the facility.
In September, an FDA audit of Divi’s Laboratories Limited API facility in Visakhapatnam (Vizag), India – known as Unit-2 – ended with a Form 483 detailing six observations.
But Divi’s has since issued a note on the Bombay Stock Exchange announcing the closure of the audit.
“We wish to inform you that we have now received an Establishment Inspection Report (EIR) from US-FDA for our Unit-II, as closure of audit by FDA.”
Meanwhile, a Dr Reddy’s Laboratories finished formulation facility in Duvvada, Andhra Pradesh has also received an FDA EIR but the audit remains open, the firm said, also in a regulatory filing this week.
“In the cover letter to the EIR, FDA has explained that the inspection has not closed and the site’s status remains unchanged, but that FDA has released the EIR in order to be transparent about its regulatory process.”
“We are planning to request a re-inspection in 2018 after further discussion on scheduling with FDA,” the firm said.