FDA Inspection 1034598 — HLPR, Inc.
The FDA completed an inspection of HLPR, Inc. on Dec 5, 2017 in Hamel, MN. 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
- Dec 5, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hamel, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |