USFDA issues warning letter to Intas Pharma for Sanand plant
Intas Pharmaceuticals for manufacturing lapses, including failure of its quality control unit to ensure CGMP compliance, at its Sanand-based manufacturing plant. In a warning letter dated July 28, 2023, the US Food and Drug Administration (USFDA) pointed out various manufacturing lapses at the plant.
«This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals,» the USFDA said. It further 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 inspected the manufacturing facility from November 22 to December 2, 2022.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. The USFDA said the company «failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity.» It further said: «You failed to ensure reliability of data relating to the quality of medicines produced at your facility.
Our inspection revealed serious deviations, including but not limited to, inadequate oversight of original CGMP documents, deficient controls over computerised systems, insufficient laboratory investigations, and aborted chromatographic sequences.» Senior facility managers failed to exercise their authority and responsibility to ensure reliable data, leading to severe data integrity deficiencies in production and laboratory departments, it added. «Our investigators observed plastic bags filled with torn and discarded original CGMP documents in your quality
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