In November, regulators overseeing pharmaceutical standards in the U.S. identified deficiencies in quality control procedures at the Bloomington facility of Catalent, a contract drug manufacturer. These issues included the detection of a “pest” on the production line, as documented in an inspection report. Novo Holdings, the parent organization of Novo Nordisk, unveiled plans to acquire Catalent in a significant transaction valued at $16.5 billion.
As part of this acquisition, Novo Holdings will gain control of Catalent’s Bloomington plant. Subsequently, Novo Holdings intends to divest the Bloomington facility to Novo Nordisk, a move aimed at enhancing production capabilities for their widely-used weight-loss medication, Wegovy.
Catalent currently serves as the primary provider of fill-finish services for Wegovy, handling the critical tasks of packaging syringes and injection pens under sterile environments.
Eli Lilly, a prominent competitor of Novo Nordisk in the obesity drug market, also relies on Catalent for the manufacturing of some of its pharmaceutical products. However, Lilly, headquartered in Indianapolis, refrained from commenting on whether Catalent’s Bloomington facility contributes to the production of its drugs.
During the inspection conducted by the U.S. FDA at Catalent’s Bloomington plant from October 31 to November 15, several observations were documented. Among these observations was Catalent’s failure to adequately investigate unexplained discrepancies in specific product batches, highlighting areas for improvement in their quality control processes.
According to the FDA’s report, Catalent’s Bloomington plant showed approximately 194 deviations between October 31, 2021, and October 31, 2023. These indicate instances where certain aspects of specific batches failed to meet the required quality control standards. Alarmingly, Catalent was unable to determine the root cause of 171 of these incidents.
Among these deviations, the FDA report mentioned the discovery of a “pest,” although specific details regarding the type of creature and its exact location were redacted from the report. Additionally, the FDA highlighted deficiencies in written procedures intended to stop contamination of sterile products. During the inspection, investigators observed instances where operators’ bare faces or skin and gowns came into contact, raising further concerns about the adequacy of infection control measures.
On a separate occasion during the inspection, an “apparent brown residue” was detected on the manufacturing line, while “ink” was found in another instance.
Requests for comments from Catalent and Novo Nordisk went unanswered initially. As per the FDA’s factory inspection database, Catalent has been granted the opportunity to address the issues highlighted in the report voluntarily.
In previous years, Catalent has faced repeated violations of U.S. sterile-safety regulations, as evidenced by regulatory documents cited by Reuters in a report last year. Staff members were found to have neglected required quality checks during 2021 and 2022.
