FDA finds quality deficiencies at Catalent site

Feb. 7, 2024

The FDA has revealed troubling quality control deficiencies at Catalent's Bloomington, Indiana plant, according to an inspection report obtained by Reuters.

The recent inspection report unveiled significant issues, including the discovery of a 'pest' on the manufacturing line, prompting concerns about product safety and adherence to regulatory standards.

Conducted from October 31 to November 15, the FDA inspection identified five key observations indicating lapses in Catalent's quality control procedures. Reuters reported that the inspection report disclosed approximately 194 deviations recorded between October 31, 2021, and October 31, 2023. Alarmingly, the root cause of 171 incidents remains unidentified.

The mention of a ‘pest’ found on the manufacturing line was redacted from the report, as per Reuters sources, raising further alarm alongside noted deficiencies in procedures aimed at preventing microbial contamination. Instances of residue and ink contamination highlighted Catalent's ongoing struggle to uphold stringent quality control measures, as previously reported violations of U.S. sterile-safety regulations in previous years. 

The inspection lapses were made public just a day after Novo Holdings, parent company of Novo Nordisk, announced that it had entered into a merger agreement with Catalent in a $16.5 billion all-cash deal. As part of the agreement, Novo Nordisk acquired three Catalent fill-finish sites — the Indiana site that generated the report, as well as sites in Italy and Belgium for $11 billion, intending to use them to expand its portfolio for weight loss and diabetes treatments.