FDA Inspection
InvaDerm, Inc.InvaDerm, Inc. – FDA Inspection, Jun 28, 2023
Record Details
This FDA Inspection record concerns InvaDerm, Inc., with an inspection on June 28, 2023, covering drugs.
- Company
- InvaDerm, Inc.
- Inspection Date
- June 28, 2023
- Product Type
- Drugs
View Company Profile
ID · d3b362b7-3222-4bb6-a84a-5e302c146828
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210509
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
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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 |
| March 26, 2019 | VAI | Center for Drug Evaluation and Research | 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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