The first issues raised by the US Food and Drug Administration (FDA) is that Aurobindo does not have written procedures or controls to assure the strength, quality, purity or even identity of drug products made at the facility.
The US agency also said it was is concerned that Aurobindo has not established control procedures to assess the performance of manufacturing processes that have the potential to cause variability in finished drug products.
The audit took place between August 28 and September according to a copy of the document obtained by in-Pharmatechnologist.com.
Unit VI manufactures oral and liquid formulations of cephalosporin antibiotics for multiple markets.
The site has been the subject of US FDA criticism before, notably in 2011 when the agency issued Aurobindo with a warning letter and imposed an import ban.
The site successfully passed an FDA inspection in September of the following year and – in March 2013 – the import alert was lifted. At the time Aurobindo said the decision paved “the way for resumption of exports of 9 products to the US market.”
Aurobindo did not respond to a request for comment about the new Form 483.