GUANGDONG BIOLIGHT MEDITECH CO., LTD — FDA Facility Profile
GUANGDONG BIOLIGHT MEDITECH CO., LTD is an FDA-registered facility (FEI 3007305624) located in Zhuhai Guangdong, CN. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Apr 14, 2016: No Action Indicated (NAI)
- Inspections on record
- 2 (1 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Jan 2, 2013
- Import refusals
- 8
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 14, 2016 | No Action Indicated (NAI) | No citations listed |
| Mar 20, 2014 | Voluntary Action Indicated (VAI) | Software validation for automated processes (21 CFR 820.70(i)) Design validation - user needs and intended uses (21 CFR 820.30(g)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) Records of complaint investigation (21 CFR 820.198(e)) and 1 more |
Facility details
- Company
- GUANGDONG BIOLIGHT MEDITECH CO., LTD
- Location
- Zhuhai Guangdong (CN)
- Source
- device