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SUNDER BIOMEDICAL TECH. CO., LTD. — FDA Facility Profile

FEI 3003656001

SUNDER BIOMEDICAL TECH. CO., LTD. is an FDA-registered facility (FEI 3003656001) located in Yunlin County, TW. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Sep 13, 2017: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Sep 13, 2017
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Sep 13, 2017Official Action Indicated (OAI)Lack of or inadequate procedures for storage. (21 CFR 820.150)
Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Documentation (21 CFR 820.75(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
and 5 more

Facility details

Company
Sunder Biomedical Tech Co., Ltd.
Location
Yunlin County (TW)
Source
device

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.