A US FDA Form 483 has revealed visible foreign particles in certain batches of drug product at Catalent’s Bloomington, Indiana facility.
The Bloomington plant, which offers fill and finish services and commercial scale production, was handed a Form 483 from the US Drug and Food Administration (FDA) following an inspection at the facility between August 1 and September 1.
The 483 detailed that the FDA identified 179 occasions where particles, like black specks, foreign matter, particular matter, and foreign objects and pieces were discovered in vials produced by the contract development manufacturing organization (CDMO) .
The FDA noted in the Form 483 that the identified particles had not been “adequately investigated to include an identification of the particle in the complaint sample,” and that 17 supplier complaints were related to stopper issues.
Other observations made by the FDA included control procedure problems, in which Catalent is said to have not established equipment being used aiding the possibility of variability “in the characteristics of in-process material and the drug product.”
Furthermore, quality control issues were highlighted alongside poor maintenance of records and establishing laboratory controls.
“A recent routine FDA inspection at our Bloomington facility resulted in observations that Catalent is already addressing, as it seeks to continuously improve its operations. Production at the facility has continued without interruption. We will respond to the FDA by the deadline,” a spokesperson for Catalent told BioProcess Insider.
Key COVID-19 site
The Bloomington site entered into deals with the likes of Moderna and Johnson & Johnson (J&J) during the COVID-19 pandemic and, in April 2022, Catalent confirmed a $350 million expansion support multiple modalities.
While specific companies were not detailed in the Form 483, the FDA has released an emergency use authorization (EUA) Amendment Review Memorandum regarding Moderna’s COVID-19 vaccine, Bivalent as a single booster dose for those 18 years and older.
The document said that there have been concerns about potential supply limitations and because of this Moderna requested the FDA review and authorize specific batches of the bivalent final drug product produced at the Bloomington plant.
“In the event that [the] FDA ultimately determines that the Catalent facility was not operating in compliance with cGMP requirements at the time these batches were manufactured, Condition I in the Moderna COVID-19 Vaccine Letter of Authorization will be waived as to these batches,” the document said.