Aarti says US FDA has not detailed GMP problems that earned it an import ban

By Gareth Macdonald contact

- Last updated on GMT

Aarti banned from exporting drugs to US
Aarti banned from exporting drugs to US
Aarti Drugs says the US FDA has not provided details of observations that earned its E-22 facility in Tarapur, India an import ban.

The Indian drugmaker confirmed the US Food and Drug Administration (FDA) had banned exports from two plants in a filing with the Bombay Stock Exchange (BSE) this week​, explaining that the "facilities in Tarapur received an import alert dated March 23, 2015​.”

The plants – Plot No E-22 and G-60 Boisar​ – were banned from shipping drugs to the US as a result of unspecified good manufacturing compliance problems.

Aarti said: “For the said E-22 facility, we had a re-inspection in August 2014. Post that, we submitted four responses starting August 14 and the last response in February 15.

We still have to receive an official communication from US FDA on the import alert after which we can take immediate actions to rectify the same​” the firm added.

Aarti also pointed out that the G-60 plant was “delisted from the US FDA website couple of years back​.”

The US FDA declined to comment when contacted by in-Pharmatechnologist.com, telling us "agency communications with firms they regulate are confidential​."

Aarti said the import ban would not impact its revenue for the current fiscal year, explaining that: “US sales contribute to slightly less than 1% of the total sales volume. Hence this shouldn’t affect our top-line and bottom-line significantly​."

2013 warning

Problems at both the banned facilities were observed during an earlier inspection in 2012 and detailed in a warning letter issued to Aarti by the FDA in July 2013​.

Issues raised by the FDA in 2013​ included power outages that were not investigated despite cause disruption to Aarti’s quality control operations, analysts recording that lab tests had been completed before they had been carried out and various data discrepancies.

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