AGC Biologics Inc.
FDA inspection history in Bothell, Washington, 2016 to 2024
- 7
- Form 483s
- 1
- EIR
Every document, by year
- Form 483
- EIR
2016: one Form 483; 2018: one Form 483; 2020: one Form 483; 2021: two Form 483s; 2023: one inspection report and one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–24Seven Form 483s and one inspection report, at Bothell, Washington.
- 2020The longest 483 on file: 6 observations over 4 pages at Bothell, Washington.
Cited most
Across all AGC Biologics observations on file
- 21 CFR 211.100Written procedures; deviations7
- 21 CFR 211.192Production record review7
- 21 CFR 211.67Equipment cleaning and maintenance6
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.160General requirements2
The complete AGC Biologics file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Bothell, Washington
Seven Form 483s and one inspection report · 2016 to 2024 · 26 observations
Latest: Form 483, Mar 27, 2024 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-27 | 483 Form 483 | Bothell, Washington | 4 | $99 |
| 2023-02-10 | EIR EIR | Bothell, Washington | — | $550 |
| 2023-02-10 | 483 Form 483 | Bothell, Washington | 5 | $99 |
| 2021-07-23 | 483 Form 483 | Bothell, Washington | 3 | $99 |
| 2021-03-19 | 483 Form 483 | Bothell, Washington | — | $99 |
| 2020-11-02 | 483 Form 483 | Bothell, Washington | 6 | $99 |
| 2018-10-15 | 483 Form 483 | Bothell, Washington | 4 | $99 |
| 2016-04-22 | 483 Form 483 | Bothell, Washington | 4 | $99 |
Investigators on these documents
Michael Araneta (2)Christopher R. Czajka (2)Andrew K. Haack (2)Charles Yuan-Chia Kuo (1)Gas Aer (1)Megan Dellibovi-Ragheb (1)Mikhail Ovanesov (1)Natanie Phillips-Sylvain (1)Nataniel Phillips-Syivain (1)Nathaniel B. Phillips-Sylvain (1)On Ths Kathryn King (1)Reife Hie (1)
FEI number 3000209996 · most recent document Mar 27, 2024
About AGC Biologics Inc.
How many FDA Form 483s has AGC Biologics Inc. received?
FDA Intel has 7 Form 483s on file for AGC Biologics Inc.; the most recent is dated Mar 27, 2024.
When was AGC Biologics Inc. last inspected by FDA?
The most recent FDA inspection document on file for AGC Biologics Inc. is a Form 483 dated Mar 27, 2024, for the site in Bothell, Washington.
What did FDA cite at AGC Biologics Inc.?
The regulations cited most in the observations on file for AGC Biologics Inc. are 21 CFR 211.100 (Written procedures; deviations), 7 times; 21 CFR 211.192 (Production record review), 7 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 6 times.