FDA Inspection 1080539 — MeKo Manufacturing e.K.
The FDA completed an inspection of MeKo Manufacturing e.K. on February 21, 2019 in Sarstedt. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 21, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sarstedt (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |