FDA Inspection
AGC Biologics, Inc.AGC Biologics, Inc. – FDA Inspection, Oct 15, 2018
Record Details
This FDA Inspection record concerns AGC Biologics, Inc., with an inspection on October 15, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- People
- Arie Menachem (Issuing Officer)
- Colleen F. Hoyt (Issuing Officer)
View Company Profile
ID · 637ed58c-aa5a-437a-8630-16864734811d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109813
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
Other FDA inspections of AGC Biologics, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2025 | Not classified | Seattle District Office | |
| March 27, 2024 | Not classified | Seattle District Office | |
| February 10, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 23, 2021 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 20, 2017 | Not classified | Seattle District Office |
Other documents for AGC Biologics, Inc.
- FDA Inspection 1265749 - 2025-04-18
- FDA Inspection 1231895 - 2024-03-27
- FDA Inspection 1197098 - 2023-02-10
- FDA Inspection 1149254 - 2021-07-23
- FDA Inspection 1016289 - 2017-04-20
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