FDA Inspection
Resilience US, Inc.Resilience US, Inc. – FDA Inspection, Aug 9, 2019
Record Details
This FDA Inspection record concerns Resilience US, Inc., with an inspection on August 9, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e75da02d-7e51-4694-8e06-35b05dac8388
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099149
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.110(d)Rejected in-process materials not quarantined
- 21 CFR 211.184(e)Records of disposition of rejected material
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Resilience US, Inc.
13| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2025 | VAI | Cincinnati District Office | Drug Quality Assurance |
| March 8, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 7, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 27, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 24, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Resilience US, Inc.
- FDA Inspection 1258820 - 2025-01-21
- FDA Inspection 1043914 - 2018-03-08
- FDA Inspection 1028106 - 2017-09-07
- FDA Inspection 1018002 - 2017-06-27
- FDA Inspection 983420 - 2016-08-24
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