FDA Inspection
Speed Laboratory Inc.Speed Laboratory Inc. – FDA Inspection, Jan 8, 2013
Record Details
This FDA Inspection record concerns Speed Laboratory Inc., with an inspection on January 8, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Speed Laboratory Inc.
- Inspection Date
- January 8, 2013
- Product Type
- Drugs
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ID · 5dede9f3-815e-4097-a583-fe78168aef12
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 814874
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Speed Laboratory Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 17, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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