Dolan Central Illinois Compounding LLC dba Preckshot Professional Pharmacy – FDA 483, May 14, 2015

This FDA Form 483, issued to Central Illinois Compounding, Inc. dba Preckshot Professional, a producer of sterile drugs, details observations from an inspection conducted between April 15 and May 14, 2015. Jennifer A. Siefert is identified as the President and Co-Owner.

The inspection revealed ten observations related to sterile drug production and quality control:

1. **Inadequate Sterilization Process Validation:** Procedures to prevent microbiological contamination lack adequate validation. Specific issues include a pharmacist's gloved hands observed over open drug product containers, deficient media fills (not conducted under active conditions, fewer units filled than routine batches, and only conducted periodically), and smoke studies not performed under dynamic conditions.

2. **Deficient Environmental Monitoring:** The system for monitoring environmental conditions in aseptic processing areas is inadequate. This includes a lack of viable and non-viable particulate monitoring in ISO 5 and ISO 7 areas during active conditions, infrequent non-viable particulate monitoring during passive conditions, and infrequent surface and personnel monitoring. Additionally, pressure differentials between critical ISO areas are not continuously monitored during sterile drug production.

3. **Inadequate Protective Apparel:** Personnel garb does not adequately protect sterile drug products from contamination. Gowns, hairnets, and masks worn during aseptic filling are not sterile, leave skin exposed, and are re-used and stored improperly.

4. **Deficient Cleaning and Disinfection:** Sporicidal disinfect