FDA Inspection
Heartway Medical Products Co., Ltd.Heartway Medical Products Co., Ltd. – FDA Inspection, Jun 22, 2017
Record Details
This FDA Inspection record concerns Heartway Medical Products Co., Ltd., with an inspection on June 22, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- June 22, 2017
- Product Type
- Medical Devices & Rad Health
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ID · acfa9b8e-435f-441e-bdee-fd332ea52a57
Inspection Facts
- Inspection number
- 1016647
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Heartway Medical Products Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 27, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Heartway Medical Products Co., Ltd.
- FDA Inspection 925359 - 2015-03-11
- FDA Inspection 753535 - 2011-10-27
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