Biogen MA Inc., Research Triangle Park: FDA Inspections, Form 483s & Citations

Overview

21 FDA inspections are on record.
10 inspections produced a Form 483.
The most recent recorded inspection date is 2024-07-12.

At a glance

Inspections

Form 483s

EIRs

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

Inspection	Category	Outcome	Form 483
8 Jul 2024 – 12 Jul 2024	Biologics	Clean
7 Jun 2021 – 16 Jun 2021	Human Drugs	483	On file
7 Feb 2019 – 15 Feb 2019	Biologics	483	On file
4 Jun 2018 – 13 Jun 2018	Human Drugs	Clean
16 Mar 2017 – 23 Mar 2017	Biologics	483	On file
19 Dec 2016 – 23 Dec 2016	Human Drugs	483	On file
11 Jan 2016 – 15 Jan 2016	Human Drugs	Clean
21 Sep 2015 – 25 Sep 2015	Human Drugs	483	On file
15 Jun 2015 – 19 Jun 2015	Human Drugs	Clean
12 Nov 2014 – 14 Nov 2014	Human Drugs	483	View 483 →
12 Nov 2013 – 15 Nov 2013	Human Drugs	483	On file
30 Jul 2013 – 2 Aug 2013	Human Drugs	Clean
29 Jul 2013 – 2 Aug 2013	Human Drugs	483	On file
22 Jul 2013 – 26 Jul 2013	Biologics	483	On file
30 Sep 2011	Not recorded	483	On file
25 Sep 2009	Not recorded	Clean
29 Jan 2009	Not recorded	Clean
18 Apr 2007	Not recorded	Clean
27 Aug 2004	Not recorded	Clean
31 Jan 2002	Not recorded	Clean
2 Jun 2000	Not recorded	Clean

Observations on record

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

14 Nov 2014

21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Joseph F Owens

Investigators

FDA investigators tied to this site in the record.

Seneca D Toms3 insp.

Wayne E Seifert2 insp.

Bonita S Chester2 insp.

Adam R Cooke2 insp.

Rebecca Rodriguez2 insp.

Ibad U Khan2 insp.

Daniel Lagasse1 insp.

Laurel A Beer1 insp.

Brentley S Pittman1 insp.

Upendra K Katneni1 insp.

Cynthia Jim1 insp.

Burnell M Henry1 insp.

Thuy T Nguyen1 insp.

Viviana Matta1 insp.

Zhihao Pete Qiu1 insp.

Tamara M Casselman1 insp.

Joseph F Owens1 insp.

Donald C Obenhuber1 insp.

Jose A Cruz Gonzalez1 insp.

Marion Michaelis1 insp.

Jie He1 insp.

Priscilla M Pastrana1 insp.

Jason F Chancey1 insp.

Thomas R Berry1 insp.

Hai Lien T Phung1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

Citation	What it covers	Cited
21 CFR 211.160(b)	Cited across public-safe Form 483 observations	1x

Full site report

Get the verbatim findings behind Biogen MA Inc.'s 10 Form 483s

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