Home / Facilities / 3005669815

AMSINO MEDICAL (KUNSHAN) CO., LTD. — FDA Facility Profile

FEI 3005669815

AMSINO MEDICAL (KUNSHAN) CO., LTD. is an FDA-registered facility (FEI 3005669815) located in KUNSHAN CITY Jiangsu, CN. RegDataLab tracks 4 FDA inspections at this facility.

Reviewing AMSINO MEDICAL (KUNSHAN) 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 AMSINO MEDICAL (KUNSHAN) 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
Jun 14, 2018: No Action Indicated (NAI)
Inspections on record
4 (1 VAI, 3 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
10 or more

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
Jun 14, 2018No Action Indicated (NAI)No citations listed
May 12, 2016No Action Indicated (NAI)No citations listed
Sep 12, 2013No Action Indicated (NAI)No citations listed
Nov 4, 2010Voluntary Action Indicated (VAI)Lack of or inadequate procedures for storage. (21 CFR 820.150)

Facility details

Company
Amsino Medical (Kunshan) Co., Ltd.
Location
KUNSHAN CITY Jiangsu (CN)
Source
device

Import refusals

FDA data resources

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