Shenzhen Dongdixin Technology Co., Ltd. — FDA Facility Profile

FEI 3005170249

Shenzhen Dongdixin Technology Co., Ltd. is an FDA-registered facility (FEI 3005170249) located in SHENZHEN Guangdong, CN. RegDataLab tracks 2 FDA inspections at this facility.

Reviewing Shenzhen Dongdixin Technology Co., Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Shenzhen Dongdixin Technology Co., Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

What FDA found at this site

Latest inspection
Mar 20, 2014: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
5

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
Mar 20, 2014Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Document locations, Dissemination, etc. (21 CFR 820.40(a))
Dec 16, 2010No Action Indicated (NAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Process changes - review, evaluation and revalidation (21 CFR 820.75(c))

Facility details

Company
Shenzhen Dongdixin Technology Co., Ltd.
Location
SHENZHEN Guangdong (CN)
Source
device

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