FDA Inspection 1187361 — Barkey GmbH & Co. KG
The FDA completed an inspection of Barkey GmbH & Co. KG on November 4, 2022 in Leopoldshohe. 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
- November 4, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Leopoldshohe (Germany)
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 |
| 2431 | 21 CFR 820.30(b) | Design plans- updated |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |