"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 control (QC) scrap area under a stairwell, in your general parenteral scrap room, and on a truck outside your facility," USFDA said.
The US health regulator also pointed out the company's failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards.
"Your firm failed to establish and follow required laboratory control mechanisms...Our inspection team identified examples of your analysts entering manual integration events that yielded passing results without adequate procedural controls or justification," it noted.
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 USFDA 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.
"Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations," 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.
"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.
The warning letter issued by the USFDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.
The letter also makes clear that the company must correct the problem and provides directions and a timeframe for its plans for correction.
FDA then checks to ensure that the company's corrections are adequate.
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