Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, Andover: FDA Inspections, Form 483s & Citations

Overview

28 FDA inspections are on record.
13 inspections produced a Form 483.
The most recent recorded inspection date is 2026-04-08.

At a glance

Inspections

Form 483s

EIRs

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

Inspection	Category	Outcome	Form 483
30 Mar 2026 – 8 Apr 2026	Human Drugs	483	On file
9 Feb 2026 – 11 Feb 2026	Biologics	Clean
2 Oct 2023 – 13 Oct 2023	Human Drugs	Clean
6 Sep 2023 – 19 Sep 2023	Biologics	483	On file
19 Jul 2021 – 23 Jul 2021	Biologics	483	On file
29 Apr 2019 – 3 May 2019	Human Drugs	483	On file
14 Jan 2019 – 18 Jan 2019	Human Drugs	483	On file
4 Jan 2019 – 17 Jan 2019	Human Drugs	483	View 483 →
11 Dec 2017 – 15 Dec 2017	Human Drugs	Clean
6 Oct 2017 – 12 Oct 2017	Human Drugs	Clean
17 Apr 2017 – 28 Apr 2017	Biologics	483	On file
14 Sep 2016 – 30 Sep 2016	Human Drugs	483	On file
13 Jun 2016 – 17 Jun 2016	Human Drugs	483	On file
12 Jan 2015 – 20 Feb 2015	Human Drugs	483	On file
17 Nov 2014 – 21 Nov 2014	Human Drugs	483	On file
10 Feb 2014 – 28 Feb 2014	Human Drugs	483	On file
20 Jun 2012	Not recorded	483	On file
11 Jun 2010	Not recorded	Clean
28 Aug 2009	Not recorded	Clean
4 Jun 2009	Not recorded	Clean
28 Apr 2008	Not recorded	Clean
27 Sep 2007	Not recorded	Clean
24 Jul 2003	Not recorded	Clean
28 Feb 2003	Not recorded	Clean
8 Apr 2002	Not recorded	Clean
23 Mar 2001	Not recorded	Clean
8 Jun 2000	Not recorded	Clean
8 Oct 1999	Not recorded	Clean

Observations on record

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

17 Jan 2019

21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Sean R Marcsisin, Jee Y Chung

17 Jan 2019

21 CFR 211.160(a)

Lab controls established, including changes

Cited by Sean R Marcsisin, Jee Y Chung

17 Jan 2019

21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Sean R Marcsisin, Jee Y Chung

17 Jan 2019

21 CFR 211.160(a)

Lab controls established, including changes

Cited by Sean R Marcsisin, Jee Y Chung

Investigators

FDA investigators tied to this site in the record.

Debra M Emerson4 insp.

Sean R Marcsisin2 insp.

Erik W Koester1 insp.

Syeda N Mahazabin1 insp.

Matthew C Watson1 insp.

Robert J Martin1 insp.

Ogechi C Nna1 insp.

Gene D Arcy1 insp.

Brentley S Collins1 insp.

Priscilla M Pastrana1 insp.

Brentley S Pittman1 insp.

Kathleen R Jones1 insp.

Anissa M Cheung1 insp.

Ekaterina Allen1 insp.

Amy A Devlin1 insp.

Maxwell L Van Tassell1 insp.

Jee Y Chung1 insp.

Kara A Scheibner1 insp.

Yanming An1 insp.

Christopher D Downey1 insp.

Stacey S Degarmo1 insp.

Wayne E Seifert1 insp.

Christina A Capacci-Daniel1 insp.

Zhihao Pete Qiu1 insp.

Arie Menachem1 insp.

Burnell M Henry1 insp.

Christian Lynch1 insp.

Paula A Trost1 insp.

Joyce A Rockwell1 insp.

Martha T Olone1 insp.

Justine M Corson1 insp.

Dawn M Braswell1 insp.

Brenda P King1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

Citation	What it covers	Cited
21 CFR 211.160(a)	Cited across public-safe Form 483 observations	4x

Full site report

Get the verbatim findings behind this site's 13 Form 483s

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