FDA 483 - Compound Preferred LLC - March 01, 2017

This FDA Form 483 details significant deficiencies at a facility producing sterile and non-sterile drug products, including Eylea 2mg/0.05mL injection.

**Key Violations and Observations:**

* **Microbiological Contamination Prevention (Observation 1):** Procedures are not established, written, or followed. This includes using a non-UHEPA vacuum in an ISO 7 cleanroom, failure to perform media fills for production operators (105 batches produced without required media fills), and improper storage of previously worn sterile gloves. * **Environmental Monitoring Deficiencies (Observation 2):** The environmental monitoring (EM) procedure (SOP 08-004) is inadequate, relying on third-party certifiers every six months. Viable and non-viable air sampling, surface sampling in the ISO 5 laminar flow hood (LFH), and daily personnel monitoring are not performed during sterile drug production. Additionally, the ISO 5 LFH and adjacent ISO-classified areas were not recertified after expiration on 12/31/16, leading to 19 lots of sterile drug product being produced without proper certification. * **Aseptic Area Cleaning and Disinfection (Observation 4):** Non-sterile wipes and non-sterile 70% isopropyl alcohol (IPA) are used to clean critical surfaces. Drug containers and components are placed into the ISO 5 LFH