Frontida Biopharm said it had full knowledge of issues at a manufacturing plant in Philadelphia it recently bought from Mutual Pharmaceutical, a subsidiary of India’s Sun Pharmaceutical, that was hit with a FDA warning letter.
The plant, which employs about 250 people, was slapped with a warning letter from the regulatory agency this summer in the wake of a month-long inspection of the facility that occurred between mid-June and mid-July of 2015. At the time, Sun still owned the the former Mutual Pharmaceuticals facility that Frontida bought for an undisclosed price in early June.
The deal was conducted “with full transparency to Frontida surrounding the FDA observations in the Form 483 citation issued following the inspection of the facility,” the company said in a statement, adding that “Sun Pharma committed, post-closing, to support Frontida in the completion of the remediation of the issues raised in the Form 483 citation, which are further raised in the warning letter that FDA issued on August 15, 2016.”
FDA inspectors found a number of serious issues at the facility that cited the plant’s quality unit for releasing 27 lots of various strengths of clonidine HCl tablets in March 2015 although there was evidence the API they were made from “was potentially contaminated.”
Additionally, the warning letter said Sun’s operation was aware in April 2015 that benzophenone had leached into felodipine tablets from the ink and varnish on the primary container label and might have been the source of stability test failure for impurities. However, plant managers failed to recall the lot until the inspectors raised questions when they revisited the facility two months later.
Inspectors also cited the plant for poor record keeping that included reports that had only one signature or were missing dates.
In the joint statement issued on Friday, Frontida said it “continues to manufacture products for Mutual at this facility, and is committed to manufacturing products that meet high standards of quality and safety.”
- here’s the statement
Frontida gets warning letter for plant it just bought from Sun
Sun unloading two U.S. plants to Chinese CRO
Sun Pharma recalls more than 216,000 bottles after label leaches chemical
Sun says 'time consuming' remediation paying off