Cipla stated via the Bombay Stock Exchange that the US Food and Drug Administration had issued a warning letter, as a part of an inspection that had resulted in a Form 483 with 12 observations.
The Indian company did not provide any additional details, only adding that it “will work closely with the agency to comprehensively address all the observations.”
The inspection of the Goa, India facility, which took place between September 16-27, found a number of issues, such as equipment and utensils not being adequately cleaned, and appropriate control over air pressure, micro-organisms and dust not being met.
In a total, the Form 483, which the FDA published on its website late last year, runs to 38 pages in length.
Despite this run in with the FDA, Cipla has seen relatively few regulatory incidents with the agency compared to fellow Indian manufacturers.
Last month, Lupin was forced to deny that it had a company-wide issue over the quality of its products, after the FDA criticized multiple sites.
During the same month, Aurobindo was also found to have problems at its oral solids manufacturing facility.