FDA Inspection
Merits Health Products Co., Ltd.Merits Health Products Co., Ltd. – FDA Inspection, Jul 14, 2011
Record Details
This FDA Inspection record concerns Merits Health Products Co., Ltd., with an inspection on July 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 14, 2011
- Product Type
- Devices
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ID · ffe83bfe-ec7b-4803-aab6-ae6f05715b2f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 734305
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184DHR content
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Other FDA inspections of Merits Health Products Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 7, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Merits Health Products Co., Ltd.
- FDA Inspection 1206643 - 2023-04-27
- FDA Inspection 813439 - 2012-11-07
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