FDA Inspection
InvaDerm, Inc.InvaDerm, Inc. – FDA Inspection, Mar 26, 2019
Record Details
This FDA Inspection record concerns InvaDerm, Inc., with an inspection on March 26, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1500a369-4887-4e66-9121-6c1485aa9d6c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084054
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of InvaDerm, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2024 | Not classified | New Jersey District Office | Drug Quality Assurance |
| June 28, 2023 | VAI | Drug Quality Assurance | |
| June 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 30, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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