FDA 483 - The Wellness Pharmacy - March 12, 2015

During an FDA inspection from March 9-12, 2015, The Wellness Pharmacy LLC, a sterile drug producer located at 2228 Papermill Rd Ste E, Winchester, VA, was cited for multiple violations. Russell T. Lederhouse, Owner, was issued the Form 483.

Key observations include: 1. **Lack of Sterility and Endotoxin Testing:** No sterile parenteral product produced since 2013 has been tested for sterility or endotoxins. 2. **Deficient Microbiological Contamination Prevention Procedures:** * Sterile drug products were produced using (b)(4) without further steps to remove endotoxin or microbial contamination, and the system was not validated. * Non-sterile patient isolation gowns and non-sterile latex gloves sprayed with a (b)(4) solution were used in sterile parenteral drug production. 3. **Deficient Control Systems:** * The (b)(4) for sterile parenteral products was in an unclassified area with (b)(4) allowing outside air entry. * No procedure for adequate (b)(4) disinfection. * The (b)(4) contained multiple objects impeding laminar air flow (e.g., red container, IV bar, plastic trays, non-sterile (b)(4) jar). * Trash receptacle in the (b)(4) was full