Spectranetics Corporation

Form 483

Fremont, California, United StatesFEI 3005462046Issued March 12, 2010

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 3005462046.

Observations4

Issue DateMarch 12, 2010

StatusNo Warning Letter

Related Inspections5

Establishment Details

Firm: Spectranetics Corporation
Location: Fremont, California, United States
FEI Number: 3005462046
Product Type: Devices
Issue Date: March 12, 2010
Country: United States

Inspection History, 2009 to 2016

NAI2

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.

Spectranetics Corporation FDA Form 483, Fremont, California, March 12, 2010