FDA Inspection
Regenerative Sciences, LLCRegenerative Sciences, LLC – FDA Inspection, Jun 16, 2010
Record Details
This FDA Inspection record concerns Regenerative Sciences, LLC, with an inspection on June 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Regenerative Sciences, LLC
- Inspection Date
- June 16, 2010
- Product Type
- Drugs
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ID · b2f12ba0-3086-4bb1-bc79-4adc11d03ed5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 668619
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
28- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(ii)Temperature / Humidity Controls
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.84(a)Components withheld from use pending release
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Other FDA inspections of Regenerative Sciences, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 15, 2009 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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