FDA Inspection
Goldway (US), IncGoldway (US), Inc – FDA Inspection, Sep 11, 2009
Record Details
This FDA Inspection record concerns Goldway (US), Inc, with an inspection on September 11, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Goldway (US), Inc
- Inspection Date
- September 11, 2009
- Product Type
- Devices
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ID · 6f0b497b-7dd8-443e-833e-4323eb22ab2a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 612178
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.20(b)(1)Responsibility, authority and independence
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Goldway (US), Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 2, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 26, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Goldway (US), Inc
- FDA Inspection 898886 - 2014-10-02
- FDA Inspection 778942 - 2012-04-26
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