ADMA Biologics, Inc.
Form 483 issued December 11, 2024 · Boca Raton, Florida
- Inspection
- Dec 3 – Dec 11, 2024
- Investigators
- Burnell M. Henry· Thai D. Truong
- Observations
- 3
- Pages
- 6
- FEI number
- 1000525461
In short: On December 11, 2024, FDA issued a Form 483 with 3 observations to ADMA Biologics, Inc. in Boca Raton, Florida (FEI 1000525461) after an inspection that ran Dec 3 – Dec 11, 2024. The investigators were Burnell M. Henry and Thai D. Truong. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile are not…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
The firmADMA Biologics, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ADMA Biologics, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected ADMA Biologics, Inc.?
Burnell M. Henry and Thai D. Truong are named on this Form 483, for the inspection of Dec 3 – Dec 11, 2024. Each investigator has a profile showing what they cite most.
When was ADMA Biologics, Inc. inspected by FDA?
The inspection ran Dec 3 – Dec 11, 2024, and the Form 483 is dated December 11, 2024.
How do I get the full Form 483 for ADMA Biologics, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.