USFDA issues warning letter to ex-Sun Pharma US facility
The Philadelphia plant is among the two facilities that Sun Pharma had sold to Frontida BioPharm in June this year, along with 15 products, for an undisclosed amount
New Delhi: The USFDA has found significant violations of current good manufacturing practice (CGMP) norms at a plant in Philadelphia that was earlier owned by Sun Pharmaceutical and has issued a warning letter to its current owner, Frontida BioPharm.
The Philadelphia plant is among the two facilities that Sun Pharma had sold to Frontida BioPharm in June this year, along with 15 products, for an undisclosed amount.
In a letter to Frontida BioPharm CEO Song Li, the USFDA said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated..."
The USFDA had inspected the drug manufacturing facility from 15 June to 17 July, 2015.
The health regulator said the quality unit knowingly released 27 lots of various strengths of clonidine HCl tablets on or about March 5, 2015, despite evidence that active pharmaceutical ingredient (API) used in their manufacture was potentially contaminated.
The quality unit of the plant failed to ensure CGMP-related records are accurate, contain appropriate documentation and are consistent with your standard operating procedure, the letter added.
The FDA has warned the Frontida BioPharm to correct the violations cited in this letter "promptly".
"Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction," the letter said.
It, however, does not mention Sun Pharma or its executives.
At the time of selling the units, Sun Pharma did not mention anything about the FDA inspections and had simply stated that it was selling the plants as part of its manufacturing consolidation in the US.
The company had earlier received a final approval from USFDA in March 2015 for this product
These older drug products belong to erstwhile Ranbaxy Laboratories and are not being marketed in the US since 2008
The therapeutic 2-step Kamedis Bio-Herbal Dandruff Care System is used for treating itching and flaking associated with dandruff and seborrheic dermatitis