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.

"This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," the US drug regulator said in a warning letter dated July 28, 2023.

A warning letter is issued by the USFDA in case it finds that a manufacturer has significantly violated its regulations.

"Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated." the regulator said.

In the warning letter, the USFDA said that the company doesn't meet established specifications for identity, strength, quality, and purity. "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."

"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 USFDA said.

The USFDA inspected the manufacturing facility from November 22 to December 2, 2022.

The USFDA pointed out that in previous inspections, including those which took place between May 20-28, 2019, similar CGMP observations were cited at the plant. The regulator has now sought a detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment among other things.

"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," it said.

Failure to address violations may also result in the FDA continuing to refuse admission of articles manufactured at the facility into the US market, the USFDA noted.