FDA Inspection 604368 — Shamrock Medical Solutions Group LLC
The FDA completed an inspection of Shamrock Medical Solutions Group LLC on August 11, 2009 in East Taunton, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 11, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Taunton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |