Atlas

FDA-Inspected Site

AstraZeneca Pharmaceuticals LP

13 FDA inspections are on record for AstraZeneca Pharmaceuticals LP in Philadelphia, United States.

Clean· No action indicated

Philadelphia, United States · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 9 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-06-24.

At a glance

Inspections

13

Form 483s

9

EIRs

2

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
17 Jun 2025 – 24 Jun 2025BiologicsClean
11 Jul 2022 – 22 Jul 2022Biologics483View 483 →
12 Jun 2018 – 20 Jun 2018Biologics483On file
12 May 2015 – 20 May 2015Biologics483On file
14 May 2013 – 22 May 2013Biologics483On file
3 May 2011Not recorded483On file
23 Jun 2010Not recorded483View 483 →
7 Dec 2009Not recorded483View 483 →
9 Oct 2009Not recorded483On file
16 Jun 2009Not recorded483View 483 →
11 Jul 2007Not recordedClean
26 Jul 2006Not recordedClean

Observations on record

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

22 Jul 2022
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Unnee Ranjan

22 Jul 2022
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Unnee Ranjan

22 Jul 2022
21 CFR 211.63

Equipment Design, Size and Location

Cited by Unnee Ranjan

23 Jun 2010
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Prabhu P Raju

23 Jun 2010
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Prabhu P Raju

Investigators

FDA investigators tied to this site in the record.

Jacqueline M Diaz Albert2 insp.
Susan M Jackson2 insp.
Christian Lynch2 insp.
Ann M Montemurro2 insp.
Richard L Bartlett1 insp.
Lizaida Perez1 insp.
Unnee Ranjan1 insp.
Gene D Arcy1 insp.
Prabhu P Raju1 insp.
Joan A Loreng1 insp.
Susan S Yu1 insp.
Edward Patten1 insp.
Paula A Trost1 insp.
Lindan E Silvers1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations4x
21 CFR 211.192Cited across public-safe Form 483 observations4x
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(b)Cited across public-safe Form 483 observations1x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 600.14(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 600.14(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind AstraZeneca Pharmaceuticals LP's 9 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