FDA Inspection 1007913 — Hiossen Inc.
The FDA completed an inspection of Hiossen Inc. on Apr 12, 2017 in Fairless Hills, PA. 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 12, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fairless Hills, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |