FDA 483 - Turbare Manufacturing - January 24, 2025

This FDA Form 483 details seven observations from an inspection.

**Observation 1** highlights a failure to thoroughly review unexplained discrepancies. Specifically, mold growth (Curvularia intermedia) was found on personnel during a media fill, but no investigation into its origin or patient safety impact was conducted, despite the firm's procedure requiring action for mold. Additionally, an investigation into a fingertip monitoring OOS result was delayed for two months without justification, and lot disposition decisions were made prior to the investigation opening, with no documented record of the rejected and destroyed lot.

**Observation 2** states that acceptance criteria for quality control sampling are inadequate. The firm's AQL sampling of (b)(4) of the batch is not statistically significant, and acceptance criteria are not appropriately applied. For Avastin repackaged lot (b)(4), two major defects (particulate matter) were found in (b)(4) syringes, exceeding the AQL limit, yet the batch was released without investigation. Similarly, for Avastin repackaged lot (b)(4), one major defect (underfill) was found during AQL after a 200% visual inspection, but the AQL was passed without further action.

**Observation 3** notes that control procedures are not established to validate manufacturing processes. The visual inspection qualification kit contains approximately (b)(4) defects, and the firm's classification of critical, major, and minor defects is not