FDA EIR - Boehringer Ingelheim Fremont, Inc. - April 13, 2023

The FDA conducted a routine pre-approval inspection of Boehringer Ingelheim Fremont, Inc. from April 11-13, 2023, in Fremont, CA. This inspection, conducted under Compliance Program 7346.832 for Pre-Approval Inspections, specifically focused on the Injectable Delivery Device component of their Cyltezo (adalimumab-adbm) Autoinjector, 40 mg/0.8 mL, for Biologics License Application 761058/Supplement 16. The regulatory framework also referenced compliance programs for combination products and licensed biological therapeutic drug products, operating under the broader oversight of the FD&C Act.

During this recent inspection, FDA investigators reviewed various documents, including process validation, commercial batch records, deviation logs, and calibration records. Notably, no significant objectionable conditions were identified. This finding contrasts with a previous FDA inspection conducted from October 25 to November 4, 2022, which resulted in a "Voluntary Action Indicated" (VAI) classification. That prior inspection yielded a Form FDA 483 observation regarding the firm's quality control unit, specifically that its responsibilities and procedures were not adequately documented or followed. Although seven additional items were discussed during the closeout of the previous inspection, their corrections were not re-evaluated during the current pre-approval inspection.

The company manufactures and packages its own Cyltezo products and also contract manufactures Keytruda (pembrolizumab) bulk drug substance. The absence of significant issues in this latest inspection suggests a positive status for the specific pre-approval scope, with no new required actions identified. No samples were collected, and no refusals or recalls were reported.