MacroGenics, Inc
FDA inspection history in Rockville, Maryland, 2021 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Two Form 483s, at Rockville, Maryland.
- 2021The longest 483 on file: 8 observations over 5 pages at Rockville, Maryland.
Cited most
Across all MacroGenics observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.192Production record review1
The complete MacroGenics file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Rockville, Maryland
Two Form 483s · 2021 to 2023 · 11 observations
Latest: Form 483, Aug 28, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-28 | 483 Form 483 | Rockville, Maryland | 3 | $99 |
| 2021-04-06 | 483 Form 483 | Rockville, Maryland | 8 | $99 |
Investigators on these documents
FEI number 3010195035 · most recent document Aug 28, 2023
About MacroGenics, Inc
How many FDA Form 483s has MacroGenics, Inc received?
FDA Intel has 2 Form 483s on file for MacroGenics, Inc; the most recent is dated Aug 28, 2023.
When was MacroGenics, Inc last inspected by FDA?
The most recent FDA inspection document on file for MacroGenics, Inc is a Form 483 dated Aug 28, 2023, for the site in Rockville, Maryland.
What did FDA cite at MacroGenics, Inc?
The regulations cited most in the observations on file for MacroGenics, Inc are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time.