RTI Surgical, Inc. dba RTI Biologics, Inc.

Form 483

Alachua, Florida, United StatesFEI 3002719998Issued July 10, 2015

View Form 483 PDF

Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3002719998.

Observations6

Issue DateJuly 10, 2015

StatusNo Warning Letter

Establishment TypeHuman Tissue and Medical Device Manufacturer

Related Inspections9

Establishment Details

Firm: RTI Surgical, Inc. dba RTI Biologics, Inc.
Location: Alachua, Florida, United States
FEI Number: 3002719998
Establishment Type: Human Tissue and Medical Device Manufacturer
Product Type: Devices
Issue Date: July 10, 2015
Country: United States

Inspection History, 2010 to 2026

NAI5

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.

RTI Surgical, Inc. dba RTI Biologics, Inc. FDA Form 483, Alachua, Florida, July 10, 2015