FDA Inspection 922854 — Almo-Erzeugnisse Erwin Busch GmbH
The FDA completed an inspection of Almo-Erzeugnisse Erwin Busch GmbH on Mar 12, 2015 in Bad Arolsen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 12, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bad Arolsen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |