FDA 483 - Hartley Medical Center Pharmacy, Incorporated - July 08, 2015

This FDA Form 483 was issued to Hartley Medical Center Pharmacy, Incorporated, a producer of sterile drugs located at 113 W Victoria St, Long Beach, CA 90805-2162. The inspection was conducted from June 29, 2015, to July 8, 2015. William A. Stuart, RPh, President, was the recipient of the report.

The inspection revealed six observations:

1. **Inappropriate Personnel Clothing:** Personnel preparing sterile drug products did not wear goggles, exposing skin around the neck and eyes. Non-sterile gowning materials (scrub pants, scrub jacket, bouffant, face mask) were worn in the aseptic area, and cleanroom pants and jackets were reused throughout the day. 2. **Deficient Environmental Monitoring:** Personnel monitoring and surface sampling in LAF hoods were not performed daily when final drug products were prepared. 3. **Inadequate Cleaning and Disinfection:** No sporicidal agent was used in the cleanroom. The Germicidal Solution used for cleaning the aseptic area was not rendered sterile prior to use, and non-sterile materials were used to clean LAF hood surfaces. 4. **Insufficient Sterilization Process Validation:** Media fills did not adequately simulate the batch process for up to (b)(4) units. 5. **Lack of Final Product Testing:** Final drug products in pre-