FDA Inspection
Shamrock Medical Solutions Group LLCShamrock Medical Solutions Group LLC – FDA Inspection, Mar 5, 2013
Record Details
This FDA Inspection record concerns Shamrock Medical Solutions Group LLC, with an inspection on March 5, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 5, 2013
- Product Type
- Drugs
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ID · 005b2dfc-577b-4109-84db-d0524ba03212
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 817578
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.130(e)Packaging line inspection after use
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Shamrock Medical Solutions Group LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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