FDA Inspection
Dermazone LLCDermazone LLC – FDA Inspection, Apr 11, 2019
Record Details
This FDA Inspection record concerns Dermazone LLC, with an inspection on April 11, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 676e6519-f0e4-444d-9874-8c50f117ee67
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086039
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.72(b)Calibration procedures - content
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Other FDA inspections of Dermazone LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 24, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 1, 2012 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| November 5, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dermazone LLC
- FDA Inspection 951835 - 2015-11-24
- FDA Inspection 806119 - 2012-11-01
- FDA Inspection 544410 - 2008-11-05
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