Form 483

Revive Rx LLC dba Revive Rx Pharmacy Form 483, 2025-02-07

FDA issued a Form 483 to Revive Rx LLC dba Revive Rx Pharmacy on 2025-02-07 with 7 public-safe observations.

483· Form 483 issuedHuman Drugs7 observations

Revive Rx LLC dba Revive Rx Pharmacy · Houston, United States · Issued February 7, 2025

Overview

  • 7 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

7 Feb 2025
FDCA 501(a)(2)(A)

Exposed to lower quality air/ISO 5

Cited by Jazmine N Brown

7 Feb 2025
FDCA 501(a)(2)(A)

Failure to clean and disinfect/sterilize equipment, ISO 5 area

Cited by Jazmine N Brown

7 Feb 2025
FDCA 501(a)(2)(A)

Inadequate smoke studies

Cited by Jazmine N Brown

7 Feb 2025
FDCA 501(a)(2)(A)

Lack of/inadequate, environmental monitoring

Cited by Jazmine N Brown

7 Feb 2025
FDCA 501(a)(2)(A)

Lyophilizers, inadequately or not sterilized

Cited by Jazmine N Brown

Inspected site

RRRevive Rx LLC dba Revive Rx PharmacyHouston, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
FDCA 501(a)(2)(A)Cited across public-safe Form 483 observations7x

Source document

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PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 7 observations

The source PDF, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere