FDA 483 - American Specialty Pharmacy - August 05, 2015

From July 29 to August 5, 2015, the FDA inspected American Specialty Pharmacy, a producer of sterile drug products located at 10 Medical Pkwy Ste 105, Dallas, TX 75234-7838. The inspection, issued to owner Abdul Hameed, revealed ten observations regarding deficiencies in sterile drug product manufacturing.

Key violations include: 1. **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination were not followed. This included failure to disinfect components before bringing them into the ISO 5 hood, use of non-sterile absorbent pads, opening sterile wipes in a non-ISO 5 area, and technicians not re-spraying gloves with sterile alcohol after moving hands in and out of the ISO 5 hood. 2. **Aseptic Processing Area Monitoring:** Environmental monitoring of aseptic processing areas was deficient. Only initial monitoring of ISO 5 and Laminar Flow was performed since January 2015, with no additional monitoring. Initial qualification showed out-of-compliance results for two locations with no documented investigation. The firm also failed to conduct environmental monitoring at required frequencies per SOP. 3. **Protective Apparel:** Non-sterile protective apparel (facemask, shoe covers, hair covers, disposable lab coat, and no sterile eye goggles) was worn during sterile product preparation, exposing facial skin. 4. **Cleaning and Disinfecting