FDA 483 - Coastal Meds, LLC - September 23, 2015

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

**Facility and Operations:** The facility manufactures sterile drug products, including Lipo-Den Extreme, Pyridoxine, Lipo-Plex, Lipo-Den, Lipo-Den Plus, Cyanocobalamin, Methylcobalamin, Hydroxocobalamin, Lipo-Den Max, Rodex, Adeno-Plex, and Methyl-Plex.

**Violations and Observations:**

* **Aseptic Processing Area Deficiencies:** * Environmental monitoring (surface and air) of the ISO 5 environment (room and laminar flow hood) is not performed daily when sterile products are produced, contrary to procedure 1114-02. * Pressure differentials between the ante room (ISO 7) and clean room (ISO 5), and between the ante room and non-classified area, are not monitored due to absent gauges, despite procedure 1114-04. * No evidence of constant airflow pressure in the ante room with a sink near the ISO 5 room. * ISO 5 environment certification does not occur under dynamic conditions. * Observed approximately 1-inch air gaps at the bottom of doors to the ante room and from the ante room to the ISO 5 room. * **Personnel Clothing:** Employees wore