Ongoing issues at Sun Pharma’s production facility in Gujarat, India, have resulted in the FDA putting the facility on import alert status.
The company announced the move by the U.S. regulatory agency in a filing (PDF) dated Sept. 9. The company said that as a result of a June 2-13 inspection of the plant, the FDA classified the site "Official Action Indicated," meaning the facility is not following good manufacturing practices.
“The Halol facility is under Import Alert, resulting in the refusal of shipments from the facility into the U.S., barring certain exemptions due to drug shortage, until the facility becomes fully compliant with FDA and CGMP standards,” the company said, adding that it is committed to working with the FDA and maintaining good manufacturing standards at all of its facilities.
The import ban is a result of ongoing issues at the site, which had previously been cited for poor aseptic behavior and inadequate environmental monitoring. Similar findings were again observed during the June inspection.
The latest inspection resulted in a 19-page rebuke that listed eight observations, including repeat problems flagged by the FDA in a warning letter in 2022.
During the June visit, inspectors found Sun did not establish and follow procedures meant to prevent microbiological contamination. Specifically, the focus was on the facility’s gloving and aseptic gowning practices, where an operator’s gown made contact with a trash can and another worker was seen handling vials with gloved hands as opposed to forceps.
The inspection also uncovered improper batch testing in the plant's quality unit, potentially incomplete control records and shoddy equipment.
Further, an FDA inspector saw liquid dripping from the ceiling cracks in a stability chamber. The dripping liquid passed through what appeared to be potential "bacterial, fungal and mold” growth. The stability chamber in question houses sterile drug products for U.S. and other markets, the FDA noted at the time.
The Gujarat plant previously earned an FDA import alert in 2022.