FDA Inspection 914682 — Apex Medical (Kunshan) Corp.
The FDA completed an inspection of Apex Medical (Kunshan) Corp. on February 4, 2015 in Kunshan. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 4, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kunshan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3198 | 21 CFR 820.40(b) | Document changes, review and approval, communication |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |