FDA Inspection
Cheen Houng Enterprise Co., Ltd.Cheen Houng Enterprise Co., Ltd. – FDA Inspection, Dec 17, 2009
Record Details
This FDA Inspection record concerns Cheen Houng Enterprise Co., Ltd., with an inspection on December 17, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 17, 2009
- Product Type
- Devices
View Company Profile
ID · 782c5ce7-dbfc-4e56-93df-2b477e459b47
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 638732
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.184(e)ID label, labeling
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Cheen Houng Enterprise Co., Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 22, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 21, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 8, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cheen Houng Enterprise Co., Ltd.
- FDA Inspection 1237498 - 2024-04-10
- FDA Inspection 1074500 - 2018-11-22
- FDA Inspection 969359 - 2016-04-21
- FDA Inspection 844111 - 2013-08-08
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