Dexcowin Co. Ltd.

Form 483

Geumcheon, -, Korea (the Republic of)FEI 3007065358Issued August 31, 2017

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3007065358.

Observations16

Issue DateAugust 31, 2017

Status1 Related Warning Letter

Related Inspections5

Establishment Details

Firm: Dexcowin Co. Ltd.
Location: Geumcheon, -, Korea (the Republic of)
FEI Number: 3007065358
Product Type: Devices
Issue Date: August 31, 2017
Country: Korea (the Republic of)

Inspection History, 2011 to 2023

NAI1

VAI2

OAI2

NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Dexcowin Co. Ltd. FDA Form 483, Geumcheon, August 31, 2017