FDA Inspection 1236465 — PB-Kunststoffverarbeitung Ballerstedt Gmbh
The FDA completed an inspection of PB-Kunststoffverarbeitung Ballerstedt Gmbh on Apr 18, 2024 in Reinbek. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 18, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Reinbek (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |