Overview
- 14 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-27.
At a glance
Inspections
14
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Mar 2025 – 27 Mar 2025 | Biologics | Clean | |
| 30 Jan 2023 – 1 Feb 2023 | Biologics | Clean | |
| 8 Apr 2019 – 11 Apr 2019 | Biologics | Clean | |
| 6 Mar 2017 – 10 Mar 2017 | Biologics | Clean | |
| 15 Jun 2015 – 19 Jun 2015 | Biologics | Clean | |
| 20 Feb 2015 | Biologics | Clean | |
| 9 Jun 2014 – 19 Jun 2014 | Biologics | 483 | View 483 → |
| 22 Jul 2013 – 2 Aug 2013 | Biologics | Clean | |
| 14 Nov 2012 | Not recorded | Clean | |
| 23 Aug 2012 | Not recorded | 483 | View 483 → |
| 30 Aug 2011 | Not recorded | Clean | |
| 20 Sep 2010 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
Establish, maintain and follow manufacturing SOPs
Cited by Brandy D Brown, Randy L Clarida, Cordelia J Brammer, Brandy Davis Brown
Schedules and procedures for equipment & calibration
Cited by Brandy D Brown, Randy L Clarida, Cordelia J Brammer, Brandy Davis Brown
Person performing, test results, interpretation
Cited by Brandy D Brown, Randy L Clarida, Cordelia J Brammer, Brandy Davis Brown
Following manufacturer's instructions
Cited by Randy L Clarida, Cordelia J Brammer, Kimberly C Delk-Brooks
Establish, maintain and follow manufacturing SOPs
Cited by Randy L Clarida, Cordelia J Brammer, Kimberly C Delk-Brooks
Investigators
FDA investigators tied to this site in the record.
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 | 2x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.100(b)(15) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.170(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 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