FDA Inspection 867558 — Boule Medical AB
The FDA completed an inspection of Boule Medical AB on February 6, 2014 in Spanga. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 6, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Spanga (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |