Panacea Biotec has received a Warning Letter from the USFDA relating to its pharma formulation facility at Baddi, Himachal Pradesh, owned by the Company’s unlisted wholly-owned subsidiary, Panacea Biotec Pharma.
The regulator issued a warning letter which state, “This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.
The observations made by the US FDA are as follows:
The company failed 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.
Panacea Biotec failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
“Until you correct all violations completely and we confirm your compliance with CGMP (current good manufacturing practice), FDA may withhold approval of any new drug applications or supplements listing your firm as a drug manufacturer,” said the regulator.
After receiving the letter, Panacea Biotec issued a statement which informs, “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.
The statement also adds that the company will actively engage with the agency and take all necessary steps required to address USFDA concerns. Panacea Biotec is also in the process of providing a thorough and comprehensive response to the USFDA within the statutory time permitted in the letter.
“This 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. Further, US revenues from the said facility is not significant as compared to total revenues of the Company and PBPL. The USFDA may, however, withhold approval of any new drug applications or supplements till PBPL addresses all issues raised by the agency,” says the statement.