Atlas

FDA-Inspected Site

AstraZeneca Pharmaceuticals LP

15 FDA inspections are on record for AstraZeneca Pharmaceuticals LP in Gaithersburg, United States.

Clean· No action indicated

Gaithersburg, United States · Last updated July 9, 2026

Overview

  • 15 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-01-14.

At a glance

Inspections

15

Form 483s

2

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
5 Jan 2026 – 14 Jan 2026Human DrugsClean
21 Oct 2024 – 25 Oct 2024Human DrugsClean
20 May 2024 – 31 May 2024Human Drugs483View 483 →
17 Jan 2024 – 22 Jan 2024Human DrugsClean
11 Jul 2023 – 18 Jul 2023Human DrugsClean
22 Sep 2021 – 30 Sep 2021Human DrugsClean
22 Feb 2021 – 26 Feb 2021Human DrugsClean
19 Oct 2020 – 27 Oct 2020Human DrugsClean
2 Oct 2018 – 11 Oct 2018Human DrugsClean
31 Jan 2018 – 5 Feb 2018Human DrugsClean
18 Sep 2017 – 20 Sep 2017Human DrugsClean
6 Dec 2016 – 9 Dec 2016Human DrugsClean

Observations on record

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

31 May 2024
21 CFR 211.192

Investigations of discrepancies, failures

Cited by James R Birkenstamm, Ekaterina Allen, Jazmine N Brown

31 May 2024
21 CFR 211.194(a)(4)

Complete Test Data

Cited by James R Birkenstamm, Ekaterina Allen, Jazmine N Brown

31 May 2024
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by James R Birkenstamm, Ekaterina Allen, Jazmine N Brown

31 May 2024
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by James R Birkenstamm, Ekaterina Allen, Jazmine N Brown

20 Mar 2013
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Nebil A Oumer

Investigators

FDA investigators tied to this site in the record.

David L Chon3 insp.
John Dan3 insp.
Lee Hong Pai Scherf2 insp.
Melanie N Daniels2 insp.
Lucilla Facchin1 insp.
Brittany L Carpenter1 insp.
James R Birkenstamm1 insp.
Ekaterina Allen1 insp.
Jazmine N Brown1 insp.
Hector J Colon-Torres1 insp.
Yangmin Ning1 insp.
Jean M Mulinde1 insp.
Bei Yu1 insp.
Robin R Waller1 insp.
Charles R Bonapace1 insp.
Brandon L Mariner1 insp.
Nebil A Oumer1 insp.
Ana P Barido1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(1)(i)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind AstraZeneca Pharmaceuticals LP's 2 Form 483s

Source PDFs, verbatim observations, 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