Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-07.
At a glance
Inspections
11
Form 483s
6
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Mar 2024 – 7 Mar 2024 | Biologics | Clean | |
| 15 Apr 2019 – 22 Apr 2019 | Biologics | 483 | View 483 → |
| 9 Jan 2017 – 26 Jan 2017 | Biologics | 483 | View 483 → |
| 20 Feb 2014 – 5 Mar 2014 | Biologics | 483 | View 483 → |
| 28 Jun 2012 | Not recorded | 483 | View 483 → |
| 23 Aug 2011 | Not recorded | 483 | View 483 → |
| 24 Nov 2009 | Not recorded | 483 | View 483 → |
| 8 Apr 2005 | Not recorded | Clean | |
| 9 Sep 2004 | Not recorded | Clean | |
| 10 Sep 2003 | Not recorded | Clean | |
| 13 Feb 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Apr 2019
21 CFR 211.194(a)(8)
Identification of Person Performing Review of Lab Records
Cited by Ismael Olvera-Iv
22 Apr 2019
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Ismael Olvera-Iv
26 Jan 2017
21 CFR 211.194(a)(8)
Identification of Person Performing Review of Lab Records
Cited by Kelly D Moore
Investigators
FDA investigators tied to this site in the record.
Daniel P Stlaurent3 insp.
Kelly D Moore2 insp.
Sunitha K Rajaram1 insp.
Conor J Mccarron1 insp.
Ismael Olvera-Iv1 insp.
Theressa B Smith1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.100(b)(12) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.160(e)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 640.2(c)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 640.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 640.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.195(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.195(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(b)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.120 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.21(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.21(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.25(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.61 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 6 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