FDA 483 - Denver Solutions, LLC DBA Leiters Health - February 23, 2018

This FDA Form 483 details observations from an inspection of a drug product manufacturing facility.

**Facility and Operations:** The inspection observed the production of Phenylephrine HCl injection, 100 mcg/mL. Aseptic processing areas, including ISO 5 and ISO 7 rooms, were central to the observations.

**Violations and Observations:**

1. **Failure to Reject Non-Conforming Products:** On February 14, 2018, two filled syringes of Phenylephrine HCl injection, lot 1730021, were found with unidentified black material embedded in their walls. The firm's visual inspection process failed to detect these defects. One affected syringe was in released inventory, and the other was a reserve sample. 2. **Deficient Environmental Monitoring:** * **Inadequate Surface Sampling:** On February 14, 2018, the QC Supervisor did not sample all equipment used during production on February 13, 2018, failing to follow approved procedures. Specifically, a material cart used to hold components and moved throughout the ISO 7 room, and one of two extensively used tables in the middle of the room, were not sampled. The procedure also lacked a mechanism to ensure all equipment in the ISO 7 room was sampled due to a lack of unique identification markings for support equipment (chairs, carts, tables). * **Inadequate