FDA Inspection 756491 — Easymed Instruments Co., Ltd.
The FDA completed an inspection of Easymed Instruments Co., Ltd. on Nov 24, 2011 in Foshan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 24, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Foshan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |