The USFDA inspected the facility from August 26 to September 6, 2024.
“Our investigators observed significant contamination in multiple ducts of non-dedicated use in the preparation of finished drug products manufactured at your facility,” the USFDA stated.
While filters were installed to prevent contamination, inadequate cleaning and maintenance processes rendered them ineffective, it added.
“Swab samples collected from the ducts by your firm during the inspection, specifically from areas after the high-efficiency particulate air filters, detected residues from multiple previously manufactured drug products and were too numerous to count microbial contamination,” the US health regulator stated.
The company failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair, it added. “Bird droppings and feathers were observed during the inspection in the AHU area, specifically on the air purification units, ducts…and on the floors…inside your drug manufacturing facility,” it charged. In response to this letter, provide a plan and timeline to implement routine, vigilant operations management oversight of facilities, the USFDA said.
This plan should ensure, among other things, prompt detection of facility contamination issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the facility infrastructure, and improved systems for ongoing management review, it added.
The USFDA also pointed out that a large amount of torn CGMP records were discovered in at least 15 plastic waste bags during the inspection, including analytical balance printouts and worksheets containing manufacturing and testing data.
“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” it stated.
This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, the USFDA said.
“Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated,” it added.
“FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.”
It further stated: “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”.
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 provide directions and a timeframe for its plans for correction.
USFDA then checks to ensure that the company’s corrections are adequate.
