front door pharmacy, llc – FDA Warning Letter, Mar 18, 2019

On July 1, 2020, the FDA issued a Warning Letter to Front Door Pharmacy, LLC dba Pure Pharmaceuticals, following an inspection from February 25 to March 18, 2019. The inspection revealed serious deficiencies in the production of sterile drug products, rendering them adulterated under FDCA Section 501(a)(2)(A).

Key violations included: 1. **Personnel Practices:** Aseptic processing with exposed skin in the ISO 5 laminar airflow (LAF) hood, including bare hands and uncovered wrists. 2. **Facility and Equipment Cleanliness:** Visibly dirty equipment (mixer with foreign residue, black dust-like residue on a (b)(4) in ISO 7 Cleanroom, oily/powder residue on a stainless-steel table in ISO 7 Anteroom) and difficult-to-clean surfaces (cloth-like stool covering). 3. **Inadequate Cleaning and Disinfection:** ISO 5 LAF hood powered off until shortly before use and not disinfected with sporicidal agent; use of unlabeled, non-sterile (b)(4) and (b)(4) for disinfection; no sporicidal agent used in aseptic processing areas. 4. **Airflow and Environmental Control:** Failure to perform adequate smoke studies under dynamic conditions for ISO 5 area; ceiling air vents adjacent to HEPA filters potentially preventing proper air circulation. 5. **Cross-