FDA Inspection 739541 — Shamrock Medical Solutions Group LLC
The FDA completed an inspection of Shamrock Medical Solutions Group LLC on August 24, 2011 in Lewis Center, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 24, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lewis Center, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |