FDA Inspection
Speed Laboratory Inc.Speed Laboratory Inc. – FDA Inspection, Aug 20, 2026
Record Details
This FDA Inspection record concerns Speed Laboratory Inc., with an inspection on August 20, 2026, issued by the Atlanta District Office, covering human drugs.
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ID · d4b461f0-2be5-42ad-a3e2-21e23b8583f1
Inspection Facts
- Inspection number
- 1331886
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Speed Laboratory Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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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