Cipla has been hit with a scathing 23-page Form 483 in the wake of an FDA inspection of one of its manufacturing facilities in India.
In the report, the FDA cited failures in numerous testing and record-keeping procedures and a plethora of customer complaints.
The inspection, which took place throughout most of February at the company’s Pithampur, India, facility, found more than 3,000 complaints were filed with the company between 2020 and 2022. More than 90% of the customer complaints centered on product performance issues.
The report, which contained redacted details throughout, said Cipla failed to conduct evaluations of the complaints to determine whether further market action was warranted. Further, the company didn’t take proper action to reduce the number of complaints, the FDA said.
Additionally, inspectors found a truck loaded with “bags of scrap” that also contained documents pertaining to lab samples and a list of employees who work in the manufacturing areas.
Cipla was also cited for failing to do a complete review of discrepancies in a batch of products and for failing to report an incident where it found a microorganism in a drug batch.
Among the eight observations outlined in the report, the company also failed to investigate the effects of power failures on product quality. The agency said there have been eight power failures there since January 2021.
Back in March of 2020, the FDA slammed Cipla with a warning letter for failing to address cross-contamination and out-of-spec shipments for drugs produced at the manufacturer's sterile products plant in Goa, India. In that warning, the company was accused by the FDA of failing to address observations raised in the administration's Form 483 following a site inspection the previous September.
That inspection found product residue around air filters and on equipment. Investigators also criticized the plant for using non-dedicated equipment to make and ship products to the U.S.