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483
•Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals)•June 7, 2021

Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals) – FDA 483, Jun 7, 2021

Record Details

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.

Company
Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals)
Inspection date
June 7, 2021
Product type
drugs
Office
Division of Human and Animal Food Operations - West III
Person
  • Camerson E. Moore (Microbiologist)
View Company Profile

ID · cba29edc-1ce9-4c44-b85c-483c955b6b7b

Violation Codes5
FD&C Act 801(a)(3)21 CFR 21121 CFR 21021 CFR 331(c)21 U.S.C. 324(a)(4)

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Other documents for Front Door Pharmacy, LLC dba Pure Pharmacy (Pure Pharmaceuticals)
  • 483 - 2019-03-18March 18, 2019

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