FDA Inspection
Shamrock Medical Solutions Group LLCShamrock Medical Solutions Group LLC – FDA Inspection, Aug 11, 2009
Record Details
This FDA Inspection record concerns Shamrock Medical Solutions Group LLC, with an inspection on August 11, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 11, 2009
- Product Type
- Drugs
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ID · 91307aa7-4f15-403f-8826-26b04962bc8e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 604368
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Shamrock Medical Solutions Group LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 4, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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