FDA 483 - MedisourceRx - October 22, 2020

The FDA Form 483 details multiple deficiencies observed during an inspection.

**Facility and Operation Details:** The document pertains to a drug product manufacturing facility producing Glutathione and Aviptadil, including both vial and syringe presentations. Operations involve 100% visual inspection, aseptic processing, media fills, and compounding.

**Violations and Observations:**

* **Inadequate Discrepancy Review (Repeat Observation):** Major defects from 100% visual inspection were not thoroughly investigated. * Unknown particles in multiple Glutathione and Aviptadil drug product lots were not identified. * Investigations for media fill lots exceeding particulate action limits (e.g., Syringe lots (b)(4) and (b)(4)) were inadequate, with conclusions (e.g., aggregate from (b)(4) media) unconfirmed. * No effort was made to identify particles in media fill vial product lots (e.g., lots (b)(4), (b)(4), (b)(4), (b)(4)). * The (b)(4)% alert/action limits for major defects in visual inspection and discontinuation of (b)(4) inspection in drug product release were not justified.

* **Inadequate Aseptic and Sterilization Process Validation:** * Not all media fill units from Nov 2019 (syringes) and Feb 202