FDA 483 - Diamondback Drugs of Delaware, LLC - May 17, 2013

The FDA Form 483 details significant deficiencies at a facility producing sterile drug products, including Buprenorphine HCl vials.

**Environmental Monitoring and Aseptic Processing Deficiencies:** * **Lack of Active Monitoring:** No active viable or non-viable particulate air monitoring during aseptic processing in ISO 5 hoods or ISO 7 cleanrooms. Monitoring is only conducted statically by an outside contractor. * **Pressure Differential Monitoring:** No active monitoring of cleanroom pressure differentials during processing; gauges are absent or unread. * **Personnel Monitoring:** No post-shift monitoring of personnel gloves or arms in ISO 5 hoods. * **Insufficient Frequency:** Environmental monitoring of ISO 5 hood and ISO 7 cleanroom surfaces is conducted infrequently by an outside contractor.

**Sterilization Process Validation and Control Issues:** * **Inadequate Media Fills:** Media fills do not represent actual production conditions (duration, batch size, environmental details). * **Out-of-Specification Certification:** An ante-room exceeded non-viable particulate specifications during certification but was still certified without re-sampling. * **Lack of Smoke Studies:** No recording of smoke studies for ISO 5 hoods, and no smoke studies performed in ISO 7 cleanrooms. * **Sterilization Process Validation:** No (b)(4) testing for the sterilizing step of drug products like Buprenorphine HCl. * **Component Ster