Children's Healthcare Of Atlanta IRB FDA Record
- Latest inspection NAI · Nov 7, 2025
- No warning letters matched by name
Children's Healthcare Of Atlanta IRB has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Children's Healthcare Of Atlanta IRB" is on file.
- Latest inspection
- Nov 7, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 3 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Children's Healthcare Of Atlanta IRB: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 7, 2025 | Atlanta, GA | Biologics | No Action Indicated (NAI) | 3004112734 |
| Jan 26, 2017 | Atlanta, GA | Drugs | No Action Indicated (NAI) | 3004112734 |
| Nov 23, 2010 | Atlanta, GA | Drugs | Voluntary Action Indicated (VAI) | 3004112734 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004112734 | Atlanta, GA | 3 | Nov 7, 2025 |
Children's Healthcare Of Atlanta IRB and the FDA: common questions
Has Children's Healthcare Of Atlanta IRB received an FDA warning letter?
No FDA warning letter addressed to the name "Children's Healthcare Of Atlanta IRB" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Children's Healthcare Of Atlanta IRB received an FDA Form 483?
FDA has not published a Form 483 for "Children's Healthcare Of Atlanta IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Children's Healthcare Of Atlanta IRB?
The most recent FDA inspection on file ended Nov 7, 2025 at Atlanta, GA and was classified NAI. FDA has 3 inspections of Children's Healthcare Of Atlanta IRB on file.
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