FDA inspection

BioTissue Holdings Inc: FDA inspection ending Feb 6, 2018

FDA inspection 1040962 · Voluntary Action Indicated (VAI) · Doral, FL

Key facts

Inspection ID 1040962
Firm BioTissue Holdings Inc
FEI number 3009809074
Address 7000 SW 97th Ave Ste 214
City Doral
State FL
ZIP 33122
Country United States
Fiscal year 2018
Inspection end date Feb 6, 2018
Classification Voluntary Action Indicated (VAI)
Project area Blood and Blood Products
Product type Biologics

At a glance

  • 10–99 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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