The facility is owned by the company’s wholly-owned unlisted subsidiary Panacea Biotec Pharma Ltd (PBPL), the company said in a BSE filing.
“The company/ PBPL has taken multiple steps after the inspection of the facility conducted during February 10 to 20, 2020 to address the observations received from USFDA during the inspection,” it added.
The company will actively engage with the agency and take all necessary steps required to address the United States Food and Drug Administration (USFDA) concerns, Panacea Biotec said.
Panacea Biotec/PBPL is also in the process of providing a thorough and comprehensive response to the USFDA within the statutory time permitted in the letter, it added.
The warning letter does not materially affect the existing business of the company/PBPL in the US and the existing product supplies from the said pharmaceutical formulations facility will continue, the filing noted.
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 MDÂ Rajesh Jain,Â the US health regulator has flagged that during the inspection of the facility, its investigators observed specific violations, including failure by theÂ 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.