# FDA 483 - Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals) - March 18, 2019

Source: https://www.keypedia.com/records/483/front-door-pharmacy-llc-dba-pure-pharmacy-pure-pharmaceuticals/dd178ac8-7cb3-4e8c-9e15-f5da44a17cfa

> FDA 483 for Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals) on March 18, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals)
- Inspection Date: 2019-03-18
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: An FDA Form 483 inspection identified multiple deficiencies at a facility compounding sterile and non-sterile drugs, including P-105 Injection.

**Personnel and Aseptic Processing:**
*   A pharmacist was observed with exposed skin (gloves not extending over gown sleeves) during aseptic compounding of P-105 Lot #030719@1.
*   The pharmacist touched surfaces outside the ISO 5 area and re-entered without re-sanitizing gloves.
*   The pharmacist's hands were completely exposed inside the ISO 5 hood prior to sterile compounding.

**Environmental Control and Disinfection:**
*   Non-sterile drug components (Phentolamine Mesylate USP, Mannitol USP, Papaverine HCL) and a mixer were not disinfected before entering the ISO 5 aseptic processing area.
*   The stool in the ISO 7 Cleanroom was covered with a material that could not be adequately disinfected.
*   Unlabeled bottles of non-sterile isopropyl alcohol were used to disinfect ISO 5 hood surfaces and found in ISO 8 and ISO 7 areas.
*   The firm failed to validate the sporicidal agent (Spor-Klenz) used in cleanrooms and aseptic processing areas.

**Facility Design and Air Quality:**
*   Air returns adjacent to HEPA filters in the ISO 8 Anteroom and ISO 7 Cleanroom allowed poor quality air

## Related Documents

- [483 - 2021-06-07](https://www.keypedia.com/records/483/front-door-pharmacy-llc-dba-pure-pharmacy-pure-pharmaceuticals/cba29edc-1ce9-4c44-b85c-483c955b6b7b)
- [483 - 2021-06-07](https://www.keypedia.com/records/483/front-door-pharmacy-llc-dba-pure-pharmacy-pure-pharmaceuticals/e5afc942-9f5d-4784-8faa-526e2e384947)

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Company: https://www.keypedia.com/companies/front-door-pharmacy-llc-dba-pure-pharmacy-pure-pharmaceuticals/8a9bfa54-2a1a-40d2-a6f5-f85b4334e937

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9