FDA Inspection 922246 — Medsource, Inc.
The FDA completed an inspection of Medsource, Inc. on March 31, 2015 in Tiverton, RI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 31, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tiverton, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12419 | 21 CFR 1271.265(a) | Evaluation--microorganisms, damage |
| 12425 | 21 CFR 1271.265(c)(1) | Release of HCT/Ps by responsible person |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3141 | 21 CFR 820.150(a) | Storage procedures to prevent mix-ups |
| 4058 | 21 CFR 820.20 | Management responsibility |