FDA Inspection 987433 — Spectrum Plastics Group
The FDA completed an inspection of Spectrum Plastics Group on October 3, 2016 in Saint Louis Park, MN. 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
- October 3, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Saint Louis Park, MN (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |