Grifols Diagnostic Solutions, Inc., Emeryville: FDA Inspections, Form 483s & Citations

Overview

19 FDA inspections are on record.
10 inspections produced a Form 483.
The most recent recorded inspection date is 2025-10-31.

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
27 Oct 2025 – 31 Oct 2025	Biologics	483	View 483 →
4 Dec 2024 – 13 Dec 2024	Biologics	483	On file
1 Dec 2021 – 7 Dec 2021	Biologics	483	On file
7 Feb 2019 – 15 Feb 2019	Biologics	483	On file
19 Sep 2016 – 28 Sep 2016	Biologics	483	On file
22 Jan 2014 – 29 Jan 2014	Biologics	Clean
6 May 2013 – 10 May 2013	Human Drugs	483	On file
24 May 2012	Not recorded	483	On file
30 Mar 2012	Not recorded	483	View 483 →
17 Jun 2011	Not recorded	Clean
16 Jul 2010	Not recorded	Clean
15 Jul 2010	Not recorded	483	On file
18 Sep 2008	Not recorded	483	On file
1 Feb 2008	Not recorded	Clean
23 Jan 2007	Not recorded	Clean
26 May 2005	Not recorded	Clean
24 Sep 2004	Not recorded	Clean
17 Apr 2003	Not recorded	Clean
28 Sep 2001	Not recorded	Clean

Observations on record

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

31 Oct 2025

21 CFR 312.53(c)(1)

Investigator statement (FDA 1572)

Cited by Cynthia J Tsui

30 Mar 2012

21 CFR 820.25(b)

Training - Lack of or inadequate procedures

Cited by Lydia S Chan

Investigators

FDA investigators tied to this site in the record.

Omotunde O Osunsanmi3 insp.

Jeffrey M Watson3 insp.

Gene D Arcy2 insp.

Cynthia J Tsui1 insp.

Nisha C Patel1 insp.

Brentley S Collins1 insp.

Eileen A Liu1 insp.

Jacqueline M Diaz Albert1 insp.

Jacqueline M Diaz Albertini1 insp.

Mihaly S Ligmond1 insp.

Paula A Trost1 insp.

Daniel J Roberts1 insp.

Lance M De Souza1 insp.

Rebecca Rodriguez1 insp.

Lydia S Chan1 insp.

Christian Lynch1 insp.

Cynthia Jim1 insp.

Henry K Lau1 insp.

Mei-Chiung J Huang1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

Citation	What it covers	Cited
21 CFR 312.53(c)(1)	Cited across public-safe Form 483 observations	1x
21 CFR 820.25(b)	Cited across public-safe Form 483 observations	1x

Full site report

Get the verbatim findings behind Grifols Diagnostic Solutions, Inc.'s 10 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