FDA Inspection 834617 — Dongguan Mars Medical Products Co., Ltd.
The FDA completed an inspection of Dongguan Mars Medical Products Co., Ltd. on May 30, 2013 in Shatian. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- May 30, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Shatian (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |