FDA Inspection 682638 — Flexicare Medical (Dongguan) Ltd.
The FDA completed an inspection of Flexicare Medical (Dongguan) Ltd. on August 26, 2010 in Dongguan. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 26, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dongguan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |