BioTissue Holdings Inc

Form 483FOIA Uncovered

Doral, Florida, United StatesFEI 3009809074Issued July 16, 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 3009809074.

Observations5

Issue DateJuly 16, 2019

StatusNo Warning Letter

Related Inspections10

Establishment Details

Firm: BioTissue Holdings Inc
Location: Doral, Florida, United States
FEI Number: 3009809074
Product Type: Devices
Issue Date: July 16, 2019
Country: United States

Inspection History, 2013 to 2026

NAI4

VAI5

OAI1

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.

BioTissue Holdings Inc FDA Form 483, Doral, Florida, July 16, 2019