FDA Inspection
Avadim Holdings IncAvadim Holdings Inc – FDA Inspection, May 22, 2025
Record Details
This FDA Inspection record concerns Avadim Holdings Inc, with an inspection on May 22, 2025, issued by the Atlanta District Office, covering human drugs.
- Office
- Atlanta District Office
- Person
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ID · 01da8fb3-3dda-408c-9286-64c492075406
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1270610
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Avadim Holdings Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 4, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 31, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Avadim Holdings Inc
- FDA Inspection 1084850 - 2019-03-06
- FDA Inspection 993645 - 2016-11-04
- FDA Inspection 580182 - 2009-03-31
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