FDA Inspection 1063743 — Amann Girrbach North America, L.P.
The FDA completed an inspection of Amann Girrbach North America, L.P. on August 29, 2018 in Charlotte, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 29, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |