FDA Inspection
Shandex Personal Care Manufacturing Inc.Shandex Personal Care Manufacturing Inc. – FDA Inspection, Nov 28, 2014
Record Details
This FDA Inspection record concerns Shandex Personal Care Manufacturing Inc., with an inspection on November 28, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 28, 2014
- Product Type
- Drugs
View Company Profile
ID · 5e66e1ed-8a15-444f-8be8-c81a97ffd38d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 908758
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Shandex Personal Care Manufacturing Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Shandex Personal Care Manufacturing Inc.
- FDA Inspection 1032398 - 2017-09-29
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