FDA Inspection 1194801 — Access Point Technologies EP, Inc.
The FDA completed an inspection of Access Point Technologies EP, Inc. on Dec 20, 2022 in Rogers, 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 20, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rogers, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |