Company
ChinaGUANGDONG BIOLIGHT MEDITECH CO., LTD, Zhuhai, China – FDA Inspections
Inspection records and compliance data for GUANGDONG BIOLIGHT MEDITECH CO., LTD in Zhuhai. 4 FDA inspections on record, 2 Form 483s, 1 warning letter, last inspected September 05, 2024.
Company Profile
This profile covers GUANGDONG BIOLIGHT MEDITECH CO., LTD based in Zhuhai, China.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 1
First inspected March 20, 2014. Last inspected September 5, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - user needs and intended uses1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 5, 2024 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1249761 |
| October 12, 2017 | Not classified | Medical Devices & Rad Health | 1043345 |
| April 14, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 977307 |
| March 20, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 873587 |
FDA documents
Form 483s (1)
Warning Letters (1)
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Company Information
Name
GUANGDONG BIOLIGHT MEDITECH CO., LTD
FEI Number
3007305624
Address
Technology Innovation Coast Hi, No. 2 Innovation First Road; Tech Zone, Zhuhai, China
Country
China
ID: a9077544-a39a-4a5f-af41-7b536f0b299f