FDA Inspection
DSP Skin Care LLCDSP Skin Care LLC – FDA Inspection, Sep 9, 2021
Record Details
This FDA Inspection record concerns DSP Skin Care LLC, with an inspection on September 9, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- DSP Skin Care LLC
- Inspection Date
- September 9, 2021
- Product Type
- Drugs
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ID · 8df32d87-8ae2-41b8-9634-66028e3e5702
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1151795
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
12- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(d)Expiration date location on labeling
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of DSP Skin Care LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2023 | 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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