MacroGenics, Inc
Form 483 issued April 6, 2021 · Rockville, Maryland
- Inspection
- Mar 24 – Apr 6, 2021
- Investigator
- Jeanne Fringer
- Observations
- 8
- Pages
- 5
- FEI number
- 3010195035
In short: On April 6, 2021, FDA issued a Form 483 with 8 observations to MacroGenics, Inc in Rockville, Maryland (FEI 3010195035) after an inspection that ran Mar 24 – Apr 6, 2021. The investigator was Jeanne Fringer. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 7 of 8 observations.
Most cited: 21 CFR 211.160 (3×)
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
Your firm has not established adequate procedural controls to protect stand-alone electronic data acquisition systems…
- 03
Service contractor’s reports and associated data for the Clean Cleanroom Certification testing of the cleanrooms and…
- 04
There is a lack of assurance that the bioassay for release and stability testing of jiu…
This inspection in context
Jeanne Fringer
6 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MacroGenics, Inc?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected MacroGenics, Inc?
Jeanne Fringer is named on this Form 483, for the inspection of Mar 24 – Apr 6, 2021. Each investigator has a profile showing what they cite most.
When was MacroGenics, Inc inspected by FDA?
The inspection ran Mar 24 – Apr 6, 2021, and the Form 483 is dated April 6, 2021.
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.