FDA 483 - Pharmacy Resources Incorporated - May 23, 2017

The FDA Form 483 details multiple deficiencies at a facility compounding sterile drug products, including Tri-Mix Injectable and erectile dysfunction sterile drug products.

Key observations include: 1. **Aseptic Processing Area Deficiencies:** Inadequate cleaning agents (expired sporicidal agent, unestablished disinfectant efficacy, insufficient contact time for sanitizing agents). Non-smooth, porous surfaces (speakers, stereo, intercom) were present in the ISO 7 cleanroom/buffer area. 2. **Environmental Monitoring Deficiencies:** Monitoring is not representative of daily sterile operations. Personnel monitoring is infrequent and limited. Viable air and surface monitoring of ISO 5 areas is only performed quarterly. Positive environmental monitoring results from 2016 and 2017 were not investigated, and alert/action limits were not determined. Missing environmental data for specific hoods and locations were also not investigated. 3. **Sterilization Process Validation:** No in situ air pattern analyses (smoke studies) were conducted under dynamic conditions for cleanrooms, laminar-flow hoods, or (b)(4), lacking assurance of critical processing area suitability. 4. **Stability Testing:** No written program or finished product sterility data to support expiration dates for erectile dysfunction sterile drug products. 5. **Protective Apparel:** Inadequate non-sterile cleanroom garb (shoe covers, hair net, face mask/shield) was worn by technicians performing aseptic filling in the ISO 5 zone