FDA Inspection
Scribe Manufacturing, Inc.Scribe Manufacturing, Inc. – FDA Inspection, Jan 26, 2012
Record Details
This FDA Inspection record concerns Scribe Manufacturing, Inc., with an inspection on January 26, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Scribe Manufacturing, Inc.
- Inspection Date
- January 26, 2012
- Product Type
- Drugs
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ID · 0b317271-2fd1-4a9a-a294-1caf3ed81bb5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 765520
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.150Written distribution procedure
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Other FDA inspections of Scribe Manufacturing, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 30, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 17, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 23, 2009 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
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