FDA Inspection
Ajinomoto Althea, Inc.Ajinomoto Althea, Inc. – FDA Inspection, Aug 7, 2019
Record Details
This FDA Inspection record concerns Ajinomoto Althea, Inc., with an inspection on August 7, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b1b2effb-263f-4083-a919-5b91d2642ddf
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1108335
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.22(a)Approve or reject components, products
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Other FDA inspections of Ajinomoto Althea, Inc.
16| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2025 | VAI | Los Angeles District Office | Drug Quality Assurance |
| September 20, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 9, 2023 | Not classified | Los Angeles District Office | |
| January 16, 2023 | Not classified | Los Angeles District Office | |
| May 25, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ajinomoto Althea, Inc.
- FDA Inspection 1266794 - 2025-05-09
- FDA Inspection 1218719 - 2023-09-20
- FDA Inspection 1223371 - 2023-02-09
- FDA Inspection 1195170 - 2023-01-16
- FDA Inspection 1142663 - 2021-05-25
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