FDA Inspection 832955 — Parks Medical Electronics, Inc
The FDA completed an inspection of Parks Medical Electronics, Inc on May 30, 2013 in Aloha, OR. 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
- May 30, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Aloha, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |