FDA Inspection
Resilience Biotechnologies, Inc.Resilience Biotechnologies, Inc. – FDA Inspection, Aug 8, 2018
Record Details
This FDA Inspection record concerns Resilience Biotechnologies, Inc., with an inspection on August 8, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · ff29fc13-f114-4e24-8b88-f94ba7af604c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061498
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
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Other FDA inspections of Resilience Biotechnologies, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 28, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 3, 2017 | Not classified | Office of Inspections and Investigations | |
| July 26, 2013 | OAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| July 17, 2012 | OAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
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