Silver Spring( USA), 07/08/23: The United States Food and Drug Administration issued a warning letter to Intas Pharmaceuticals for manufacturing lapses at its Sanand-based manufacturing plant. The lapses include failure of the drug company’s quality control unit to ensure CGMP compliance.
The Drug Regulator stated, “This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”
The USFDA has issued a warning letter when it discovered that a manufacturer has severely breached its regulations.
The regulator stated that they have issued a letter, “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated.”
The USFDA stated in the warning notice that the corporation does not fulfil established requirements for identification, strength, quality, and purity.
They further added, “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.”
They said, “Our investigators observed plastic bags filled with torn and discarded original CGMP documents in your quality control (QC) scrap area under a stairwell, in your general parenteral scrap room, and on a truck outside your facility.”
The manufacturing facility was inspected by the USFDA from November 22 to December 2, 2022.
The USFDA noted that comparable CGMP observations were made at the plant during earlier inspections, including those conducted between May 20 and 28, 2019. The regulator has now requested a full inquiry protocol and methodology, as well as a summary of all laboratories, manufacturing operations, and systems to be assessed.
USFDA said, “After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence.”
Failure to resolve infractions may lead to the FDA continuing to refuse admission of items manufactured at the plant into the US market, according to the USFDA.
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