FDA Inspection
Skin Sake LLCSkin Sake LLC – FDA Inspection, Nov 25, 2008
Record Details
This FDA Inspection record concerns Skin Sake LLC, with an inspection on November 25, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Skin Sake LLC
- Inspection Date
- November 25, 2008
- Product Type
- Drugs
View Company Profile
ID · 8bb51bb8-0700-4f69-92b4-50fd7bf60526
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 554364
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.180(e)(1)Review of representative number of batches
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