Overview
- 14 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-03-08.
At a glance
Inspections
14
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Mar 2024 – 8 Mar 2024 | Biologics | 483 | View 483 → |
| 5 Dec 2019 – 13 Dec 2019 | Human Drugs | Clean | |
| 18 Sep 2017 – 27 Sep 2017 | Human Drugs | 483 | View 483 → |
| 12 Nov 2014 – 21 Nov 2014 | Human Drugs | 483 | View 483 → |
| 2 Jun 2014 – 13 Jun 2014 | Human Drugs | 483 | View 483 → |
| 9 Dec 2011 | Not recorded | 483 | On file |
| 30 Oct 2009 | Not recorded | 483 | View 483 → |
| 20 Jun 2007 | Not recorded | Clean | |
| 4 Aug 2006 | Not recorded | Clean | |
| 30 Dec 2005 | Not recorded | Clean | |
| 2 Nov 2004 | Not recorded | Clean | |
| 10 Mar 2003 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Mar 2024
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Jeremy L Wally, Jonah S Ufferfilge
8 Mar 2024
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Jeremy L Wally, Jonah S Ufferfilge
8 Mar 2024
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Jeremy L Wally, Jonah S Ufferfilge
8 Mar 2024
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jeremy L Wally, Jonah S Ufferfilge
Investigators
FDA investigators tied to this site in the record.
Edmund F Mrak2 insp.
Megan A Haggerty2 insp.
Jeremy L Wally1 insp.
Jonah S Ufferfilge1 insp.
Zhongren Wu1 insp.
Sean R Marcsisin1 insp.
Erik W Koester1 insp.
Jayaleka J Amarasinghe1 insp.
Elizabeth L Edwards1 insp.
Debra M Emerson1 insp.
Stacey S Degarmo1 insp.
Xiaokuang Lai1 insp.
Ramon E Martinez1 insp.
Amy C Jordan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.167(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Citra Labs, LLC'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