ADMA Biologics, Inc.
FDA inspection history in Boca Raton, Florida, 2012 to 2024
- 5
- Form 483s
Every document, by year
- Form 483
2012: one Form 483; 2018: one Form 483; 2021: one Form 483; 2024: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One Form 483, at Boca Raton, Florida.
- 2012The longest 483 on file: 13 observations over 9 pages at Boca Raton, Florida.
- 2018One Form 483, at Boca Raton, Florida.
- 2021One Form 483, at Boca Raton, Florida.
- 2024Two Form 483s, at Boca Raton, Florida.
Cited most
Across all ADMA Biologics observations on file
- 21 CFR 211.100Written procedures; deviations6
- 21 CFR 211.160General requirements4
- 21 CFR 211.192Production record review4
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.113Control of microbiological contamination2
The complete ADMA Biologics file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Boca Raton, Florida
Five Form 483s · 2012 to 2024 · 31 observations
Latest: Form 483, Dec 11, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-11 | 483 Form 483 | Boca Raton, Florida | 3 | $99 |
| 2024-12-11 | 483 Form 483 | Boca Raton, Florida | 3 | $99 |
| 2021-08-12 | 483 Form 483 | Boca Raton, Florida | 4 | $99 |
| 2018-04-12 | 483 Form 483 | Boca Raton, Florida | 8 | $99 |
| 2012-05-17 | 483 Form 483 | Boca Raton, Florida | 13 | $99 |
Investigators on these documents
Burnell M. Henry (3)Cynthia Jim (1)Jennifer L. Reed (1)Justin A. Boyd (1)Michael C. Kennedy (1)Michele L. Forster (1)Prabhu P. Raju (1)Thai D. Truong (1)
FEI number 1000525461 · most recent document Dec 11, 2024
About ADMA Biologics, Inc.
How many FDA Form 483s has ADMA Biologics, Inc. received?
FDA Intel has 5 Form 483s on file for ADMA Biologics, Inc.; the most recent is dated Dec 11, 2024.
When was ADMA Biologics, Inc. last inspected by FDA?
The most recent FDA inspection document on file for ADMA Biologics, Inc. is a Form 483 dated Dec 11, 2024, for the site in Boca Raton, Florida.
What did FDA cite at ADMA Biologics, Inc.?
The regulations cited most in the observations on file for ADMA Biologics, Inc. are 21 CFR 211.100 (Written procedures; deviations), 6 times; 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.192 (Production record review), 4 times.