FDA 483 - HHCS Pharmacy Inc. - July 28, 2014

This FDA Form 483 was issued to HHCS Pharmacy, Inc. dba Freedom Pharmacy, a producer of sterile drug products located at 3901 E. Colonial Dr., Orlando, FL 32803-4602. The inspection occurred from July 14 to July 28, 2014.

The inspection revealed eight observations:

1. **Inadequate Sterilization Process Validation:** Procedures for preventing microbiological contamination lack adequate validation. Specifically, syringe/dispensing systems used for liquid drug products from non-sterile components are not documented for sterilization, and there are no written procedures for process validation using media fill testing. A high-risk inhalation drug product (Vancomycin/Betamethasone/Tobramycin) was produced from non-sterile powders without proper validation. Media fill records for current sterile compounding technicians are incomplete or outdated.

2. **Deficient Aseptic Processing Areas:** * Rust was observed on a HEPA filter ceiling screen in the ISO 7 cleanroom. * A kitchen-grade sink with an open drain is in the anteroom, adjacent to the pass-through box used for sterile product transport. * No line of demarcation or designated gowning area exists near the ISO 7 cleanroom. * Ceilings in the cleanroom and anteroom are not sealed; cracked, water-damaged, and porous ceiling tiles were