FDA Inspection 817578 — Shamrock Medical Solutions Group LLC
The FDA completed an inspection of Shamrock Medical Solutions Group LLC on March 5, 2013 in Lewis Center, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 5, 2013
- Fiscal Year
- 2013
- 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 |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 1722 | 21 CFR 211.134(a) | Correct labels during finishing operations |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |