MacroGenics, Inc
Form 483 issued August 28, 2023 · Rockville, Maryland
- Inspection
- Aug 22 – Aug 28, 2023
- Investigator
- David A. Oluwo
- Observations
- 3
- Pages
- 3
- FEI number
- 3010195035
In short: On August 28, 2023, FDA issued a Form 483 with 3 observations to MacroGenics, Inc in Rockville, Maryland (FEI 3010195035) after an inspection that ran Aug 22 – Aug 28, 2023. The investigator was David A. Oluwo. Most observations concern quality system and laboratory controls.
At a glance
2 of 3 observations on this 483 concern 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 on-going written stability program for active pharmaceutical…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
The investigations into unexplained discrepancies are not thorough and conclusions have not been established…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmMacroGenics, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MacroGenics, Inc?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected MacroGenics, Inc?
David A. Oluwo is named on this Form 483, for the inspection of Aug 22 – Aug 28, 2023. Each investigator has a profile showing what they cite most.
When was MacroGenics, Inc inspected by FDA?
The inspection ran Aug 22 – Aug 28, 2023, and the Form 483 is dated August 28, 2023.
How do I get the full Form 483 for MacroGenics, 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.