ADMA Biologics, Inc.
Form 483 issued August 12, 2021 · Boca Raton, Florida
- Inspection
- Aug 3 – Aug 12, 2021
- Investigators
- Burnell M. Henry· Prabhu P. Raju
- Observations
- 4
- Pages
- 4
- FEI number
- 1000525461
In short: On August 12, 2021, FDA issued a Form 483 with 4 observations to ADMA Biologics, Inc. in Boca Raton, Florida (FEI 1000525461) after an inspection that ran Aug 3 – Aug 12, 2021. The investigators were Burnell M. Henry and Prabhu P. Raju. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
In-process specifications are not consistent with…
- 03
Buildings used in the manufacture and storage of plasma derived bulk drug substances and final drug…
- 04
Observation 4: scanned text, readable in the full document.
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ADMA Biologics, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected ADMA Biologics, Inc.?
Burnell M. Henry and Prabhu P. Raju are named on this Form 483, for the inspection of Aug 3 – Aug 12, 2021. Each investigator has a profile showing what they cite most.
When was ADMA Biologics, Inc. inspected by FDA?
The inspection ran Aug 3 – Aug 12, 2021, and the Form 483 is dated August 12, 2021.
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.