FDA Inspection
DSP Skin Care LLCDSP Skin Care LLC – FDA Inspection, Sep 26, 2018
Record Details
This FDA Inspection record concerns DSP Skin Care LLC, with an inspection on September 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6b9c984d-6be8-4487-b25b-4c7d78874c9f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066798
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.184(d)Labeling: documentation of exam and review
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.150Written distribution procedure
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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 9, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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