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

Source: https://www.globalkeysolutions.net/records/483/front-door-pharmacy-llc-dba-pure-pharmacy-pure-pharmaceuticals/e5afc942-9f5d-4784-8faa-526e2e384947

> FDA 483 for Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals) on June 07, 2021. 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: 2021-06-07
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: 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

## Related Documents

- [483 - 2019-03-18](https://www.globalkeysolutions.net/records/483/front-door-pharmacy-llc-dba-pure-pharmacy-pure-pharmaceuticals/dd178ac8-7cb3-4e8c-9e15-f5da44a17cfa)
- [483 - 2021-06-07](https://www.globalkeysolutions.net/records/483/front-door-pharmacy-llc-dba-pure-pharmacy-pure-pharmaceuticals/cba29edc-1ce9-4c44-b85c-483c955b6b7b)

## Related Officers

- [Microbiologist](https://www.globalkeysolutions.net/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)

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

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