Biotronik, AG

Form 483

Bulach, -, SwitzerlandFEI 3002808050Issued March 17, 2016

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 3002808050.

Observations4

Issue DateMarch 17, 2016

StatusNo Warning Letter

Related Inspections4

Establishment Details

Firm: Biotronik, AG
Location: Bulach, -, Switzerland
FEI Number: 3002808050
Product Type: Devices
Issue Date: March 17, 2016
Country: Switzerland

Inspection History, 2013 to 2019

NAI1

VAI3

NAI means No Action Indicated. VAI means Voluntary 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.

Biotronik, AG FDA Form 483, Bulach, March 17, 2016