FDA Inspection 1191128 — Almikro Gmbh & Co. Kg
The FDA completed an inspection of Almikro Gmbh & Co. Kg on November 10, 2022 in Bad Krozingen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 10, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bad Krozingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |