FDA Inspection
Shamrock Medical Solutions Group LLCShamrock Medical Solutions Group LLC – FDA Inspection, Feb 4, 2011
Record Details
This FDA Inspection record concerns Shamrock Medical Solutions Group LLC, with an inspection on February 4, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 4, 2011
- Product Type
- Drugs
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ID · 2162c63b-8f19-47db-8b34-2ba84350381b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 709022
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Shamrock Medical Solutions Group LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2009 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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