FDA Inspection
Dermarite Industries, LLC.Dermarite Industries, LLC. – FDA Inspection, Oct 10, 2018
Record Details
This FDA Inspection record concerns Dermarite Industries, LLC., with an inspection on October 10, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b92651e8-fcd0-40f8-99c2-22408073eb07
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1068298
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Dermarite Industries, LLC.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2025 | Not classified | New Jersey District Office | |
| April 8, 2025 | OAI | New Jersey District Office | Drug Quality Assurance |
| October 30, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 23, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 10, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dermarite Industries, LLC.
- FDA Inspection 1276408 - 2025-07-08
- FDA Inspection 1250450 - 2025-04-08
- FDA Inspection 1030174 - 2017-10-30
- FDA Inspection 915250 - 2015-02-23
- FDA Inspection 780318 - 2012-05-10
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