FDA Inspection
Speed Laboratory Inc.Speed Laboratory Inc. – FDA Inspection, Oct 12, 2017
Record Details
This FDA Inspection record concerns Speed Laboratory Inc., with an inspection on October 12, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a400a718-d14f-43e5-82c7-581c14a982e8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028457
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.80(a)Procedures To Be in Writing
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Other FDA inspections of Speed Laboratory Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 8, 2013 | 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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