FDA 483 - Medistat RX L.L.C. - September 18, 2014

The FDA Form 483 documents deficiencies at a facility engaged in sterile compounding and drug product manufacturing.

**Violations and Observations:**

* **Aseptic Processing Deficiencies:** * Environmental monitoring of laminar flow hoods, buffer rooms, and ante rooms is not conducted under dynamic conditions. * No scientific rationale or written specifications (air exchange rates, particle counts, pressure differential) exist for classified rooms where sterile compounding occurs. * Personnel and environmental monitoring are not performed daily when sterile products are made. * **Sterilization Process Validation:** * The sterilization process is not validated. * A specific (b)(4) unit, labeled for laboratory use only, is used to sterilize drug products from non-sterile components. * Media fills do not simulate actual production quantities or different vial sizes. * **Product Release and Quality Control:** * Drug products failing specifications are not rejected; two lots of Progesterone capsules failing potency were distributed without corrective action. * Endotoxin testing is not conducted on each batch of injectable drug products made from non-sterile components. * Growth promotion testing of agar and media for sterility analysis is not performed. * Each lot/batch of drug product is not tested for potency of each active ingredient prior to release. * **Production and Process Controls:** * No written procedures exist for