636280
Terumo Cardiovascular Systems Corporation — FEI 1828100
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 29, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3290 | 21 CFR 820.90(b)(2) | Retesting and reevaluation of reworked product |
| 3300 | 21 CFR 820.100(a)(1) | Statistical methodology |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 4189 | 21 CFR 820.198(a) | General |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 751 | 21 CFR 803.52(b)(5) | Description of the Event or Problem |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |