FDA Inspection
Dermazone LLCDermazone LLC – FDA Inspection, Nov 5, 2008
Record Details
This FDA Inspection record concerns Dermazone LLC, with an inspection on November 5, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Dermazone LLC
- Inspection Date
- November 5, 2008
- Product Type
- Drugs
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ID · 13f966de-76a8-4b85-90e3-f48e30439d6d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 544410
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.160(b)(2)In-process samples representative, identified properly
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Dermazone LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 11, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
Other documents for Dermazone LLC
- FDA Inspection 1086039 - 2019-04-11
- FDA Inspection 951835 - 2015-11-24
- FDA Inspection 806119 - 2012-11-01
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