ADMA Biologics, Inc.
Form 483 issued May 17, 2012 · Boca Raton, Florida
- Inspection
- May 9 – May 17, 2012
- Investigators
- Burnell M. Henry· Cynthia Jim· Michael C. Kennedy
- Observations
- 13
- Pages
- 9
- FEI number
- 1000525461
In short: On May 17, 2012, FDA issued a Form 483 with 13 observations to ADMA Biologics, Inc. in Boca Raton, Florida (FEI 1000525461) after an inspection that ran May 9 – May 17, 2012. The investigators were Burnell M. Henry, Cynthia Jim and Michael C. Kennedy. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
8 of 13 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (6×) · 211.110 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Cleaning validations are…
- 03
Validated process time specifications do not reflect the…
- 04
Nabi-HB in-process (b) (4) Chromatography Total IgG specifications proposed by product…
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ADMA Biologics, Inc.?
FDA listed 13 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected ADMA Biologics, Inc.?
Burnell M. Henry, Cynthia Jim and Michael C. Kennedy are named on this Form 483, for the inspection of May 9 – May 17, 2012. Each investigator has a profile showing what they cite most.
When was ADMA Biologics, Inc. inspected by FDA?
The inspection ran May 9 – May 17, 2012, and the Form 483 is dated May 17, 2012.
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.