FDA Inspection 904108 — Wassenburg Medical, Inc.
The FDA completed an inspection of Wassenburg Medical, Inc. on November 19, 2014 in Ivyland, PA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 19, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ivyland, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2649 | 21 CFR 820.30(f) | Design verification acceptance criteria |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |