FDA Inspection
CR Photoelectric Technology Co. Ltd.CR Photoelectric Technology Co. Ltd. – FDA Inspection, Aug 26, 2026
Record Details
This FDA Inspection record concerns CR Photoelectric Technology Co. Ltd., with an inspection on August 26, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- August 26, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 0f5b612e-5b4a-49d7-bd60-d41a68907abe
Inspection Facts
- Inspection number
- 1335554
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1002.30(a)(1)Quality control procedures
- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 1010.3(a)(1)ID label lacks name and address
- 21 CFR 1040.10(g)(2)(iii)Class IIIb "Danger" label
- 21 CFR 1040.10(g)(5)(i)Aperture label - laser radiation
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Other FDA inspections of CR Photoelectric Technology Co. Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2019 | Not classified | Office of Inspections and Investigations | |
| December 8, 2016 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| April 21, 2010 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| April 24, 2009 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for CR Photoelectric Technology Co. Ltd.
- FDA Inspection 1096482 - 2019-05-22
- FDA Inspection 1029911 - 2016-12-08
- FDA Inspection 667863 - 2010-04-21
- FDA Inspection 584308 - 2009-04-24
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