Overview
- 17 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-11.
At a glance
Inspections
17
Form 483s
8
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Dec 2024 – 11 Dec 2024 | Biologics | 483 | View 483 → |
| 18 Sep 2023 – 20 Sep 2023 | Biologics | Clean | |
| 3 Aug 2021 – 12 Aug 2021 | Biologics | 483 | On file |
| 12 Jul 2021 – 15 Jul 2021 | Biologics | Clean | |
| 12 Jul 2021 – 15 Jul 2021 | Biologics | Clean | |
| 3 Apr 2018 – 12 Apr 2018 | Biologics | 483 | On file |
| 26 Jan 2016 – 3 Mar 2016 | Biologics | 483 | On file |
| 5 Aug 2014 – 14 Aug 2014 | Biologics | 483 | On file |
| 17 May 2012 | Not recorded | 483 | On file |
| 14 Sep 2011 | Not recorded | Clean | |
| 10 Nov 2010 | Not recorded | 483 | On file |
| 11 Jun 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Dec 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Burnell M Henry, Jennifer L Reed, Thai D Truong
11 Dec 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Burnell M Henry, Jennifer L Reed, Thai D Truong
11 Dec 2024
21 CFR 211.42(c)(10)(iv)
Environmental Monitoring System
Cited by Burnell M Henry, Jennifer L Reed, Thai D Truong
Investigators
FDA investigators tied to this site in the record.
Burnell M Henry3 insp.
Prabhu P Raju2 insp.
Hector A Carrero2 insp.
Holly Brevig2 insp.
Omotunde O Osunsanmi2 insp.
Jennifer L Reed1 insp.
Thai D Truong1 insp.
Sheri L Stephenson1 insp.
Justin A Boyd1 insp.
Michele L Forster1 insp.
Ivan E Reyes1 insp.
Jacqueline M Diaz Albert1 insp.
Cynthia Jim1 insp.
Dawn M Mccabe1 insp.
Mihaly S Ligmond1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind ADMA Biologics, Inc's 8 Form 483s
Source PDFs 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