FDA 483 - The Medicine Shoppe - September 28, 2022

On September 26, 2022, an FDA inspection of a drug compounding lab revealed significant non-microbial contamination and inadequate controls for hazardous drug production.

Observations included: * **Residue Build-up:** Apparent residue was found around and behind the sink used for cleaning glassware and utensils. Thick, black residue was observed on a ceiling return vent, and residue build-up was present behind magnetic stir plates. * **Uncleaned Equipment:** A glass slab stored behind the sink was used to produce non-sterile human drug products (e.g., Ketoprofen/Lidocaine 20/5% cream) without prior cleaning. * **Cross-Contamination Risks:** * A non-dedicated mill was cleaned with commercially available non-pharmaceutical grade cleaning agents, potentially leaving residues, and was used for various non-sterile human drug products (e.g., topical lidocaine, gabapentin, ibuprofen, salicylic acid creams). * Clear plastic bowls used to cover pre-weighed hormonal and non-hormonal drug powders were not routinely cleaned unless visible residue was detected. Bowls with visible residue were observed covering pre-weighed hormonal powders for troches. When cleaned, a non-pharmaceutical grade detergent was used. * Non-dedicated utensils and glassware for hormonal and non-hormonal products were cleaned with a non-pharmaceutical grade detergent, and a de