FDA 483 - Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals) - June 07, 2021

This FDA Form 483 was issued to Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals), a sterile drug producer located at 8973 Interchange Dr, Houston, TX 77054-2513. The inspection was conducted from May 11, 2021, to June 7, 2021, with Henry Shiu as the PIC and Owner.

Seven observations were noted:

1. **Aseptic Manipulations:** Personnel blocked first pass air during aseptic manipulations, specifically by reaching over filled vials and placing a tray of empty vials between the HEPA filter and vials undergoing processing in the ISO 5 LAFU. 2. **Media Fills:** Media fills did not adequately simulate aseptic production operations or worst-case conditions, failing to represent actual practices like stopper placement and affixing caps. 3. **Environmental Monitoring:** Environmental monitoring was not performed in aseptic processing areas. The ISO 5 LAFU lacked a viable monitoring program during sterile drug production, and cleanroom re-certification reports for ISO 7 and ISO 8 areas did not include the ISO 5 LAFU. 4. **Sporicidal Agents:** The use of sporicidal agents was inadequate; the firm failed to validate the sporicidal agent (b)(4) Sporicidal Disinfectant Cleaner for its intended use. 5. **Facility Design/Air Quality:** Facility design