Atlas

Form 483

Direct Rx Form 483, 2017-12-15

FDA issued a Form 483 to Direct Rx on 2017-12-15 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Direct Rx · Dawsonville, United States · Issued December 15, 2017

Overview

  • 1 public-safe observation is 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.

15 Dec 2017
21 CFR 211.204

Returned drug products identified and held

Cited by Gideon N Esuzor

Inspected site

DRDirect RxDawsonville, United States

Inspection team

GNGideon N Esuzor

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.204Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, 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