Cipla was slammed with a warning letter that outlined a number of ongoing issues with the company’s manufacturing facility in Pithampur, India, which was the target of a Form 483 earlier this year.
The warning letter (PDF), which was posted on the agency’s website, outlined three major failures that led to other problems at the facility, which was inspected between February 6 and February 17 of this year.
As was outlined in the earlier Form 483, the warning letter said the facility failed to properly follow up on thousands of customer complaints regarding its albuterol sulfate inhalation aerosol used to treat bronchospasm in patients with asthma, bronchitis, emphysema, and other lung diseases. More than 3,000 complaints were filed with the company between 2020 and 2022, with more than 90% of the customer complaints centered on product performance issues.
“The number of complaints you received showed a marked and adverse trend of critical drug delivery failures which fundamentally impacted the ability of patients to use your albuterol sulfate inhalation aerosol,” the agency wrote. “Your complaint system was ineffective. For example, you emphasized the number of complaints verified in your laboratory investigation without appropriately evaluating the severity of the complaints.”
In July, Cipla issued a voluntary recall of six batches of the asthma med due to what the company described in a filing with the Bombay Stock Exchange as "a container defect," specifically related to a customer complaint of leakage in one inhaler.
The company was also cited in the warning letter for failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of sterile drug products. Inspectors found evidence the company had identified the presence of several pathogens in products, but that it failed to investigate the root cause of the problem.
Lastly, the FDA outlined the plant’s failure to establish adequate written responsibilities and procedures for its quality control unit.
Along with problems at other Cipla manufacturing facilities, the shortfalls “demonstrate that your management’s oversight and control over the manufacture of drugs is inadequate," the letter said.