US FDA warns former Sun Pharma US drug factory over quality concerns

By Sanjiv Das On Aug 27, 2016

This is one of a series of quality concerns tied to the Philadelphia, Pennsylvania factory that the FDA highlighted in an August 15 ‘warning letter’ issued to the site’s current owner, US firm Frontida BioPharm

The US Food and Drug Administration (US FDA) has pulled up a former Sun Pharmaceutical drug factory for ‘knowingly’ releasing 27 lots of the hypertension drug clonidine last year, despite proof that the raw materials used may have been contaminated.
This is one of a series of quality concerns tied to the Philadelphia, Pennsylvania factory that the FDA highlighted in an August 15 ‘warning letter’ issued to the site’s current owner, US firm Frontida BioPharm.

The plant was sold to Frontida in June by Sun Pharma, India’s number one drugmaker, which said the move was ‘a part of its manufacturing consolidation in the US.’

Sun did not mention at the time that the FDA had inspected the plant a year earlier, between June 15 and July 17, 2015, or that it expressed serious concerns with its quality standards.

Sun declined to comment on the FDA letter, while Frontida was not immediately reachable for comment.

India supplies more than 30 per cent of the drugs sold in the US, and Sun is one of several Indian companies that are under the FDA’s scanner for quality issues, after the agency increased the frequency of foreign inspections over the past two years.
At least five of Sun’s plants are barred from US exports due to quality issues, and the company has said it is working on improving its quality systems to get back US approval to supply from them.

The FDA letter is addressed to Frontida Chief Executive Sung Li, and does not mention Sun or any of its executives.
In the letter, the US regulator also outlined ‘multiple discrepancies’ that it said cast doubt on the accuracy of the quality-related records maintained at the factory.

In another observation, the FDA said that factory staff was aware by April 2015 that the chemical benzophenone had leached into some tablets of the hypertension drug felodipine from the ink and varnish on the container label, but the lots were not recalled until the FDA inspection in July 2015.