FDA Inspection 975802 — Parks Medical Electronics, Inc
The FDA completed an inspection of Parks Medical Electronics, Inc on June 17, 2016 in Aloha, OR. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 17, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Aloha, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |