Panacea Biotec Baddi plant fails to establish laboratory controls, gets USFDA warning letter
"Your firm 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, closure, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity, " the USFDA said.
New Delhi: The US Food and Drug Administration (USFDA) has issued a warning letter to Panacea Biotec for violating current good manufacturing practice norms at its Baddi plant in Himachal Pradesh. In a letter to Panacea Biotec Managing Director Rajesh Jain, the USFDA said its inspectors, from February 10-20, 2020, found significant deviations from standard manufacturing practices at the company's Baddi plant.
"This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals ...Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA said. The significant violations included the company's failure to establish laboratory controls, it added.
"Your firm 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, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity," the USFDA said.
The US health regulator noted that the company lacked data on microorganism identification from its aseptic processing operation. Besides, "Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas," it added.
Based upon the nature of the violations identified at the plant, the USFDA said it strongly recommends engaging a consultant qualified to assist the firm in meeting CGMP requirements. Until all corrections have been completed and FDA has confirmed corrections of the violations and the firm''s compliance with CGMP, FDA may withhold approval of any new applications or supplements, the USFDA said. In addition, the company's failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at the plant into the US, it added.
The FDA issued the letter on September 24 and has given the company 15 days to respond.
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