FDA Inspection
Bright Innovation LabsBright Innovation Labs – FDA Inspection, Jun 7, 2018
Record Details
This FDA Inspection record concerns Bright Innovation Labs, with an inspection on June 7, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cf0aab18-d07c-4eeb-b874-f11d2c235093
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1054722
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
22- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.84(c)(2)Containers sampled so as to prevent contamination
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.194(a)(5)Testing Calculations
- 21 CFR 211.194(a)(7)Identification of Person Performing the Testing
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Other FDA inspections of Bright Innovation Labs
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2019 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| September 16, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Bright Innovation Labs
- FDA Inspection 1111716 - 2019-10-18
- FDA Inspection 942919 - 2015-09-16
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