FDA 483 - Nubratori, Inc - July 26, 2024

The FDA Form 483 details multiple deficiencies at an outsourcing facility producing sterile drug products.

**Aseptic Process Validation and Control:** * **Inadequate Media Fill Validation:** The firm failed to perform growth promotion studies on media used for media fills (e.g., (b)(4) and (b)(4)), lacking evidence of their ability to support microbial growth. * **Product Validation Discrepancy:** Dexamethasone 24 mg/mL Injectable, Preservative Free, was validated using 2 mL (b)(4) vials, but distributed in 2 mL amber vials, despite being a light-sensitive compound. * **Incomplete Media Fill Records:** Media fill batch records did not reflect all normal production manipulations, such as the use of (b)(4) not present in sterile products, and the omission of (b)(4) control vials used for volume comparison during compounding.

**Environmental Monitoring and Aseptic Practices:** * **Deficient Personnel Monitoring:** A technician collected glove fingertip samples after wiping equipment with Sterile (b)(4), not immediately after aseptic operations, and not before planned disinfection, deviating from the Batch Production Record. * **Inadequate Cleaning/Disinfection:** An operator failed to wipe down the ISO 7 side of a (b)(4) with sterile (b)(4) (b)(4) before opening it, and failed to clean the