Apollo Care, LLC – FDA 483, Sep 8, 2021

The FDA inspection identified multiple deficiencies in the facility's quality control and aseptic processing. For Vancomycin 1.5g (Lot (b) (4)), an Out-of-Specification (OOS) potency of 116.1% was found. The investigation attributed it to laboratory error, but the contract lab could not invalidate the original result due to improper sample storage. Resamples were within specification, and the lot was released. Similarly, for Norepinephrine 8mg/250mL (Lot (b) (4)), an OOS potency of 115.2% was attributed to pump overfill. Resamples were within specification, and this lot was also released.

Aseptic technique violations were observed, including wiping medication ports outside the ISO 5 hood, employees moving between ISO 7 and ISO 8 areas without changing gloves, and inadequate environmental monitoring during critical operations (e.g., Fentanyl Citrate bulk setup lacked active air sampling and non-viable particulate monitoring). The firm's particle counter was unavailable for multiple days, leading to compounding without non-viable particle monitoring.

Facility issues included non-smooth, difficult-to-sanitize laminated work surfaces in ISO 5 areas, damaged ceiling caulk in ISO 7, adhesive residue and a protruding screw head on an ISO 7 door, and dirty/damaged door sweeps between ISO 8 and ISO 7 areas without a cleaning program. Laminar airflow