FDA 483 - Dolan Central Illinois Compounding LLC dba Preckshot Professional Pharmacy - September 19, 2017

This FDA Form 483 details observations from an inspection of Central Illinois Compounding, Inc. dba Preckshot Professional Pharmacy, a producer of sterile drugs located at 5832 N. Knoxville, Ave., Suite E, Peoria, IL 61614. The inspection was conducted from June 12, 2017, to September 15, 2017.

Key observations include:

1. **Drug Product Quality/Purity:** The firm released drug products (four lots of Tacrolimus 0.02% Oil Ophthalmic Solution and one lot of Cyclosporine Oil Ophthalmic Solution) where the strength, purity, or quality was deficient. This was due to the use of apparent food-grade ingredients, specifically [(b)(4)] and [(b)(4)], in their production.

2. **Sterilization Process Validation:** Procedures to prevent microbiological contamination lacked adequate validation. Observations included a pharmacy technician cleaning multiple vials with the same side of a sterile wipe, and the technician had not undergone a media fill validation since September 13, 2016, despite releasing sterile products since October 28, 2015.

3. **Aseptic Area Cleaning/Disinfection:** The system for cleaning and disinfecting aseptic processing areas and equipment was deficient. The ISO 7 gowning/anteroom failed ISO certification testing (integrity/[(b