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

Source: https://www.keypedia.com/records/483/front-door-pharmacy-llc-dba-pure-pharmacy-pure-pharmaceuticals/cba29edc-1ce9-4c44-b85c-483c955b6b7b

> 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: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Front Door Pharmacy, LLC dba Pure Pharmacy in Houston, TX, revealed critical deficiencies in aseptic processing and environmental controls. The firm failed to maintain adequate first-pass air, conduct proper media fills, and implement a viable environmental monitoring program. Additionally, issues included unvalidated sporicidal agents, poor cleanroom air quality, and inadequate handling of hazardous drugs, indicating significant risks to product quality and patient safety.

## Related Documents

- [483 - 2019-03-18](https://www.keypedia.com/records/483/front-door-pharmacy-llc-dba-pure-pharmacy-pure-pharmaceuticals/dd178ac8-7cb3-4e8c-9e15-f5da44a17cfa)
- [483 - 2021-06-07](https://www.keypedia.com/records/483/front-door-pharmacy-llc-dba-pure-pharmacy-pure-pharmaceuticals/e5afc942-9f5d-4784-8faa-526e2e384947)

## Related Officers

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

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/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab