Sun Pharma was issued a Form 483 from the US Food and Drug Administration (FDA) based on one observation made at the company’s Gujarat, India, facility.
The observation was based on an inspection carried out by the FDA from January 1, 2019, to February 5, 2019.
Sun Pharma released a statement on the regulatory visit, “At the conclusion of the inspection, the FDA issued a Form 483, with one observation for which the company has submitted the response.”
According to the report, the FDA issued the observation due to “a failure to thoroughly review any unexplained discrepancy.”
The agency noted that Sun Pharma had suggested out-of-specification results, obtained during re-dispersibility tests, were as a result of human error but did not seek “additional support evidence.”
The inspection was carried out as part of a pre-approval inspection of the Baska, Gujarat facility. The company noted that there is no material impact on the company.
Previously this year, Sun Pharma had to initiate a recall of close to 140,000 vials of vecuronium bromide, after the product was found to be contaminated with glass.