Drugs

Catalent Indiana FDA-483 Has Six Observations

David McFarland

— 1 min read
Share

FDA has released the form FDA-483 with six observations from a 6/23-7/14 inspection at the Catalent Indiana sterile drug manufacturing facility in Bloomington, IN. FDA gave an “Official Action Indicated (OAI)” classification to the inspection that could delay the approval and production timelines for drug products, including those from partner companies, including Regeneron and Scholar Rock, that are made at the plant. The facility, which Novo Nordisk acquired from Catalent in December 2024, has a history of FDA scrutiny that predates the acquisition. The OAI status could trigger further FDA enforcement actions, such as Warning Letters and injunctions. A facility with this classification typically requires an on-site follow-up inspection to verify that all corrective actions have been fully implemented before the status can be changed.

The inspection observations were:

  • failure of written records of investigations into the failure of a batch or any of its components to meet specifications to include always the conclusions and follow-up;
  • failure to establish and follow written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
  • aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
  • failure to establish control procedures to monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
  • failure to maintain in writing and fully follow the responsibilities and procedures applicable to the quality control unit; and
  • reports of analysis from component suppliers are accepted instead of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals.

Earlier this year, FDA released a four-page Form FDA-483 that was issued after the agency inspected the manufacturing facility 5/4-12. According to the inspection form, the facility was cited over written production and process control procedures not being followed or established. Additionally, the agency said the facility’s equipment revalidation was inadequate, and equipment and facilities were not adequately maintained or cleaned.

Read more