# FDA 483 - The Medicine Shoppe - September 28, 2022

Source: https://www.keypedia.com/records/483/the-medicine-shoppe/3d6843cc-2d03-4ca7-a022-b2124fcc9cde

> FDA 483 for The Medicine Shoppe on September 28, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Medicine Shoppe
- Inspection Date: 2022-09-28
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: 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

## Related Officers

- [Regulatory Officer ](https://www.keypedia.com/people/jill-tillman/4fd81eed-0de2-468b-a776-d4809fa91553)
- [Drug Specialist](https://www.keypedia.com/people/lauren-n-howard/538f77fe-b977-49c9-a5b3-289cf8a6e886)

Company: https://www.keypedia.com/companies/the-medicine-shoppe/e419ea29-9f02-4f54-8c26-0d31bffcbba4

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79