The API plant received a Warning Letter in February after the US Food and Drug Administration (FDA) observed cGMP violations that included a number of breaches of data integrity, and - as of Thursday – all products have been banned from being imported into the US.
The Import Alert - which allows the FDA to detain without physical examination any product from the facility including antimicrobial agents, reagents, fumigants, pH control agents, as well as APIs and formulated drug products – is the same charge as has befallen a number of Indian drug facilities of late.
Last week, Canadian firm Apotex had products manufactured at its Bangalore plant banned from being imported, whilst in March Sun Pharma had the same sanctions imposed on its facility in Karkhadi. In the past year, products have also been banned from import at Wockhardt and Ranbaxy facilities in India.
Amongst the problems described in the Warning Letter were a number of examples which raised “serious concerns regarding the integrity, reliability and accuracy of the data generated and available” at the plant.
This included, the failure to perform laboratory testing of APIs to ensure conformance to specifications and to accurately report results on Certificates of Analysis (CoA), the failure to maintain complete data derived from all laboratory tests, the failure to ensure equipment is cleaned in a reproducible and effective manner to prevent contamination, and the failure to ensure that APIs are produced according to pre-approved instructions.
“Our inspection revealed serious documentation practices and reported missing raw data,” the FDA said. “It is a basic responsibility of your quality unit to ensure that all API lots produced meet specifications that they are purported to possess.”