FDA 483 - People's Custom Rx and Clinical Care, LLC - July 24, 2019

This FDA Form 483 document outlines observations made during an inspection, indicating several deficiencies in the facility's aseptic processing and cleaning procedures.

**Facility and Operation Details:** The inspection observed the aseptic processing of "Tri-Mix, lot #07162019@34." The facility includes ISO 5 classified aseptic processing areas and cleanrooms with HEPA filters.

**Violations and Observations:** 1. **Glove Disinfection:** On July 16, 2019, an operator processing Tri-Mix (lot #07162019@34) placed gloved hands outside the ISO 5 area and did not consistently re-sanitize them before returning them under the ISO 5 hood. This indicates a failure to disinfect gloves to prevent contamination. 2. **Non-Sterile Cleaning Wipes:** On July 16, 2019, an operator used a non-sterile wipe to apply sterile (b)(4) to the exterior of the HEPA filter inside the ISO 5 hood in the cleanroom. This suggests the use of non-sterile materials in critical aseptic areas. 3. **Smoke Studies:** A review of the cleanroom certification report dated March 28, 2019, revealed that smoke studies in the ISO 5 hood were not performed under dynamic conditions. This indicates an inadequate assessment of airflow patterns and potential contamination risks