FDA Inspection
Flawless Beauty and SkinFlawless Beauty and Skin – FDA Inspection, Jan 10, 2018
Record Details
This FDA Inspection record concerns Flawless Beauty and Skin, with an inspection on January 10, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 33dbde26-fdbb-4323-a5fe-60337035bfaf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1037221
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
8- Procedural requirements
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.204Record information maintained
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of Flawless Beauty and Skin
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2015 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 16, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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