FDA Inspection
Greenway Research LabGreenway Research Lab – FDA Inspection, Aug 2, 2013
Record Details
This FDA Inspection record concerns Greenway Research Lab, with an inspection on August 2, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Greenway Research Lab
- Inspection Date
- August 2, 2013
- Product Type
- Drugs
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ID · faca4b74-d55e-4d0d-aebd-2e5df90e75b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 844973
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.166(b)Accelerated stability studies
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
Showing 10 of 14 citations.
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Other FDA inspections of Greenway Research Lab
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2011 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Greenway Research Lab
- FDA Inspection 707560 - 2011-01-27
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