Department of Health and Human Services
MUMBAI: Issues related to violations of data and manufacturing practices is back in the spotlight for the Indian pharmaceutical industry. An August 15 warning letter from the US FDA to Frontida BioPharm, a company that acquired two manufacturing units from India's Sun Pharma two months ago, pointed to discrepancies in records related to manufacturing practices.Click Here for GMP Violations/ FDA Warning Letter
The regulatory agency, which probed the site between June 15 and July 17, 2015, said the records were found to be missing out on dates and signed with only a first name besides having illegible entries in logbooks and laboratory notebooks.
When contacted a Sun Pharma spokesperson declined a comment on the matter.
In a terse letter, the FDA stated the quality unit (at the site) failed to ensure that cGMP-related (current good manufacturing practices) records are accurate, contain appropriate documentation and are consistent with its standard operating procedures.
In additional revelations of serious lapses, the FDA noted that the quality unit at the Pennsylvania drive unit knowingly released 27 lots of various strengths of clonidine tablets on or about March 5, 2015, despite evidence that active pharmaceutical ingredient (API) used in their manufacture was potentially contaminated.
The letter disclosed that the unit's vice president of quality repeatedly denied any knowledge of clonidine API supplier's recall, even though e-mail evidence collected during the inspection showed that this individual had been notified of the recall as early as July 16, 2014. During the inspection, your firm removed this individual from his position."
The warning letter said significant findings indicate that the quality unit is not fully exercising its authority and responsibilities.
On a similar ground, the US FDA added the unit failed to adequately investigate the stability failure of felodipine tablets for an "unknown impurity." It said the site officials were aware that benzophenone had leached into tablets from the ink and varnish on the primary container label, but there was no recall of the lot until July 16, 2015, during the FDA inspection.
The agency has directed Frontida to provide a plan to ensure that the quality unit exercises its full authority and ensure how it reject products that are not adequately safe and pass purity tests.
Notably, Sun Pharma informed investors recently that it has completed its remediation process at its Halol, Gujarat facility and is hoping for FDA inspection in the near term.
In June, Sun Pharma had said as part of its manufacturing consolidation in the US, it has entered into an agreement to divest two oral solid dosage manufacturing sites to Frontida BioPharm based at Philadelphia and Aurora, along with 15 related pharmaceutical products. Sun had not mentioned about the issues pointed out as part of the US FDA inspections in the press announcement.
Published by: News
Source: India Times, FDA
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