FDA Inspection
DSP Skin Care LLCDSP Skin Care LLC – FDA Inspection, Oct 12, 2023
Record Details
This FDA Inspection record concerns DSP Skin Care LLC, with an inspection on October 12, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 82d69f4e-18ea-41d5-a268-c56dca159a88
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1221605
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(c)Approve or reject procedures or specs
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Other FDA inspections of DSP Skin Care LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 26, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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