Home / Facilities / 3006113180

AYGUN SURGICAL INSTRUMENTS CO.,INC. — FDA Facility Profile

FEI 3006113180

AYGUN SURGICAL INSTRUMENTS CO.,INC. is an FDA-registered facility (FEI 3006113180) located in Kutlukent, Samsun, TR. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

Reviewing AYGUN SURGICAL INSTRUMENTS CO.,INC. 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 AYGUN SURGICAL INSTRUMENTS CO.,INC. 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
Apr 18, 2013: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Apr 18, 2013
Warning letters
1 listed by FDA for this FEI, latest Jun 27, 2013

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
Apr 18, 2013Official Action Indicated (OAI)Procedures not adequately established or maintained (21 CFR 820.40)
Design transfer - Lack of or inadequate procedures (21 CFR 820.30(h))
Lack of or inadequate procedures (21 CFR 820.100(a))
DHR content (21 CFR 820.184)
and 5 more

Facility details

Company
AYGUN SURGICAL INSTRUMENTS CO.,INC.
Location
Kutlukent, Samsun (TR)
Source
device

Compliance actions

FDA data resources

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