OPS International Inc – FDA 483, Apr 13, 2018

This FDA Form 483 details observations from an inspection of OPS International Incorporated D/B/A Olympia Pharmacy, an outsourcing facility located at 6700 Conroy Rd Ste 155, Orlando, FL, conducted from April 6-13, 2018. The inspection identified ten observations related to quality systems, manufacturing practices, and product reporting/labeling.

Key violations include: 1. **Protective Apparel:** Technicians were observed with exposed skin in ISO 5 areas and improperly gowned in ISO 7 areas, failing to protect drug products from contamination. 2. **Quality Control Unit:** Responsibilities and procedures for the quality control unit were not in writing and fully followed. 3. **Aseptic Processing Area Cleaning:** Cleaning procedures lacked documentation of contact times for disinfectants, and a hand sanitizer used on sterile gloves lacked scientific data supporting its effectiveness as a disinfectant for cleanroom use. 4. **Drug Product Release Testing:** No reconstitution specifications were established for lyophilized sterile drug products (e.g., HCG, Sermorelin) prior to release. 5. **Microbiological Contamination Prevention:** A pharmacy technician touched a door between ISO 8 and ISO 7 rooms without re-sanitizing sterile gloved hands during compounding. 6. **Environmental Monitoring:** Differential pressure readings were not recorded during sterile drug product compounding, failing to show no excursions.