Overview
- 19 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-29.
At a glance
Inspections
19
Form 483s
12
EIRs
7
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Jan 2026 – 29 Jan 2026 | Human Drugs | 483 | View 483 → |
| 18 Nov 2024 – 22 Nov 2024 | Biologics | 483 | View 483 → |
| 31 Jul 2023 – 4 Aug 2023 | Human Drugs | Clean | |
| 6 Aug 2019 – 8 Aug 2019 | Human Drugs | 483 | On file |
| 9 Jul 2018 – 13 Jul 2018 | Human Drugs | 483 | On file |
| 4 Jan 2016 – 11 Jan 2016 | Human Drugs | Clean | |
| 22 Jun 2015 – 23 Jun 2015 | Human Drugs | Clean | |
| 31 Mar 2015 – 6 Apr 2015 | Biologics | Clean | |
| 5 May 2014 – 14 May 2014 | Human Drugs | 483 | On file |
| 20 Aug 2013 – 29 Aug 2013 | Biologics | 483 | On file |
| 3 Jul 2012 | Not recorded | 483 | View 483 → |
| 4 Feb 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Jul 2012
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Rachel C Harrington
Investigators
FDA investigators tied to this site in the record.
Susan M Jackson2 insp.
Cynthia A Harris2 insp.
David L Chon1 insp.
Norman K Starks1 insp.
Charles R Bonapace1 insp.
Zhou Chen1 insp.
Mark J Seaton1 insp.
Byungja E Marciante1 insp.
Zhongren Wu1 insp.
Steven P Donald1 insp.
Chaltu N Wakijra1 insp.
Jacqueline M Diaz Albert1 insp.
Toyin B Oladimeji1 insp.
Nebil A Oumer1 insp.
Richard H Coats1 insp.
Christian Lynch1 insp.
Rachel C Harrington1 insp.
Cynthia Jim1 insp.
Rose M Ashley1 insp.
Erin L Mcfiren1 insp.
Stephanie L Shapley1 insp.
Ernest Bizjak1 insp.
Lakisha M Williams1 insp.
Daniel R Azar1 insp.
Barbara J Breithaupt1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind BioReliance Corporation's 12 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