FDA 483 - College Pharmacy, Inc. - March 15, 2013

The FDA Form 483 details numerous deficiencies at a facility engaged in aseptic processing of drug products, particularly sterile injectables.

**Facility and Operations:** The clean room, designated ISO 5 and ISO 6, has structural modifications without continuous monitoring data to support its classification. The ISO 7 gowning room and ISO 8 formula preparation area also exhibit issues.

**Violations and Observations:**

* **Cleanroom Classification & Monitoring:** * Structural modifications to the clean room are not supported by continuous monitoring. * HEPA recertification lacks leak testing and dynamic evaluations. * No routine active or non-active particulate monitoring is performed outside of review. * A stained HEPA filter (HEPA #5) above an ISO 5 workbench, caused by non-sterile product explosion, was not investigated. * Blocked return vents near HEPA #1 and #2 lacked evaluation of impact on air currents or product. * Pressure differentials are not continuously monitored between ISO 5, ISO 6, ISO 7, and ISO 8 areas. The only monitored differential (ISO 6 to ISO 7) is not continuous and reads 0.0 when the door opens. * No parameters exist for door open times between classified areas. * The ISO 7 to ISO 8 pressure differential is not maintained due to an unsealed wall-mounted