FDA 483 - Brown's Compounding Center, Inc. - July 31, 2014

This FDA Form 483 details deficiencies at a facility producing sterile drug products, including Betamethasone Injection.

**Environmental Monitoring & Control:** * **Microbial Contamination:** ISO 5 hoods, used for sterile filling, showed microbial failures in June/July 2014, but production continued without sufficient environmental monitoring frequency. * **Pressure Differentials:** No written procedures or criteria for pressure differentials. The Aseptic Room (ISO 7) was 0.13 inches water gauge, while the adjacent Vial Washing Room (ISO 8) was 0.14, indicating the ISO 7 room was not positive to all adjacent rooms. Pressure differential for the pass room/box to a common hallway was unknown/unmonitored. No documentation of pressure differentials during production. * **Monitoring Frequency:** Viable active air and non-viable particulates are not monitored during each daily production shift, only per schedule. Microbial contamination on ISO 5 work surfaces is also only scheduled, not associated with daily production. * **Personnel Monitoring:** No personnel monitoring during aseptic filling operations. Microbiological personnel surface sampling (fingers, forearm, chest) is not conducted, only gloved hand contact plate testing.

**Aseptic Process & Validation:** * **Media Fills:** Media fill procedures are inadequate. One sterile filling line (vials) has a media fill program, but the other method for Betamethasone Inj. does not.