FDA Inspection
Shamrock Medical Solutions Group LLCShamrock Medical Solutions Group LLC – FDA Inspection, Aug 24, 2011
Record Details
This FDA Inspection record concerns Shamrock Medical Solutions Group LLC, with an inspection on August 24, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 24, 2011
- Product Type
- Drugs
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ID · d19c5d0b-3e62-45f8-9da5-5fb3960d331f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 739541
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Shamrock Medical Solutions Group LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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