problems did not begin in May 2013, which is when the Waluj unit received an import alert. The EIR, which is a summary of findings over several previous inspections, says an audit was conducted in January 2012 after which an 11-item Form 483 was issued.
“Due to time constraints, uncooperative behavior of management, and significant delays in providing cGMP (current good manufacturing practices) related documentation during the course of this current inspection, the corrective actions taken in response to the previous FDA 483 could not be fully evaluated,” the EIR states.
After the issuance of Form 483 in March 22 for the Waluj facility, the USFDA issued an import alert on the facility on May 22, 2013, which prevented products manufactured in the plant from entering the US.
The regulator then escalated the issue by raising a warning letter dated July 18 on the facility after Wockhardt did not provide satisfactory responses for the steps taken to rectify the violations observed in USFDA-mandated (cGMP).