ImprimisRx CA, Inc., dba ImprimisRx – FDA 483, Mar 14, 2016

During an FDA inspection from February 23, 2016, to March 14, 2016, South Coast Specialty Compounding, Inc., a producer of sterile drugs located at 9257 Research Dr, Irvine, CA, received a Form 483 with eight observations.

Key violations include:

1. **Inadequate Sterilization Process Validation:** Procedures for preventing microbiological contamination lack adequate validation, specifically regarding media fill simulations for worst-case scenarios and lyophilization processes. 2. **Improper Personnel Garments:** The "Donning Sterile Garments" procedure is deficient as it doesn't require complete coverage of forehead and neck areas, which was observed during sterile drug filling. 3. **Deficient Environmental Monitoring:** The firm does not continuously perform active air sampling during sterile drug production, and gloved fingertip sampling procedures are inadequate. 4. **Quality Control Unit Deficiencies:** Procedures for particulate testing of sterile drug preparations are not fully followed, and there is no procedure for testing particulate matter in finished sterile drug products stored in amber vials after non-sterile to sterile, lyophilization, or sterilization processes. 5. **Inadequate Cleaning and Disinfecting Procedures:** Cleaning procedures for cleanrooms and equipment are deficient, including the use of non-sterile wipes and lack of scientific rationale for sporicidal agent use. Lyophilizer cleaning procedures are also incomplete. 6. **Cont