FDA Inspection 930545 — Heritage Medical Products, Inc.
The FDA completed an inspection of Heritage Medical Products, Inc. on April 24, 2015 in West Plains, MO. 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
- April 24, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Plains, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |