FDA Inspection 825194 — Centurion Medical Products, LP
The FDA completed an inspection of Centurion Medical Products, LP on March 19, 2013 in Williamston, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Williamston, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |