Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.)

Form 483FOIA Uncovered

Saint Paul, Minnesota, United StatesFEI 2183620Issued April 24, 2019

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 2183620.

Observations2

Issue DateApril 24, 2019

StatusNo Warning Letter

Related Inspections5

Establishment Details

Firm: Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.)
Location: Saint Paul, Minnesota, United States
FEI Number: 2183620
Product Type: Devices
Issue Date: April 24, 2019
Country: United States

Inspection History, 2011 to 2019

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.

Synovis Life Technologies, Inc. (sub. of Baxter Int'l, Inc.) FDA Form 483, Saint Paul, Minnesota, April 24, 2019