FDA Inspection
GUANGDONG BIOLIGHT MEDITECH CO., LTDGUANGDONG BIOLIGHT MEDITECH CO., LTD – FDA Inspection, Mar 20, 2014
Record Details
This FDA Inspection record concerns GUANGDONG BIOLIGHT MEDITECH CO., LTD, with an inspection on March 20, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 20, 2014
- Product Type
- Devices
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ID · a2115671-95fa-4bf5-9d87-4930f5a68e4e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 873587
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of GUANGDONG BIOLIGHT MEDITECH CO., LTD
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2024 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
| October 12, 2017 | Not classified | Office of Inspections and Investigations | |
| April 14, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GUANGDONG BIOLIGHT MEDITECH CO., LTD
- FDA Inspection 1249761 - 2024-09-05
- FDA Inspection 1043345 - 2017-10-12
- FDA Inspection 977307 - 2016-04-14
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