FDA-Inspected Site

Areva Pharmaceuticals Inc

1 FDA inspection is on record for Areva Pharmaceuticals Inc in Georgetown, United States.

483· Form 483 issued

Georgetown, United States · Last updated July 12, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-09-11.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Sep 2025 – 11 Sep 2025Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

11 Sep 2025
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Iris C Macinnes

11 Sep 2025
21 CFR 314.80(c)(2)

Late submission of annual safety reports

Cited by Iris C Macinnes

11 Sep 2025
21 CFR 314.81(b)(2)

Timely submission

Cited by Iris C Macinnes

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Areva Pharmaceuticals Inc's 1 Form 483

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat