Panacea Biotec Baddi unit gets USFDA warning letter

The USFDA may, however, withhold approval of any new drug applications or supplements till PBPL addresses all issues raised by the agency, the filing said.

"We are committed to patient safety, quality and take all quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards," it added.

In the warning letter written to Panacea Biotec MD Rajesh Jain, the US health regulator has flagged that during the inspection of the facility, its investigators observed specific violations, including failure by the firm "to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labelling, and drug products conform to appropriate standards of identity, strength, quality, and purity".

The warning letter also mentioned that the company failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Shares of Panacea Biotec closed at Rs 184.45 per scrip on BSE, down 5 per cent from its previous close.