FDA Inspection 765157 — Wassenburg Medical, Inc.
The FDA completed an inspection of Wassenburg Medical, Inc. on January 26, 2012 in Ivyland, PA. 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
- January 26, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ivyland, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |