FDA inspection

BioHorizons Implant Systems Inc: FDA inspection ending Nov 2, 2004

FDA inspection 353591 · Official Action Indicated (OAI) · Hoover, AL

Key facts

Inspection ID 353591
Firm BioHorizons Implant Systems Inc
FEI number 1000592496
Address 2300 Riverchase Ctr
City Hoover
State AL
ZIP 35244-2808
Fiscal year 2005
Inspection end date Nov 2, 2004
Classification Official Action Indicated (OAI)
Project area Compliance: Med Devices
Product type Devices
Warning letter UCM146732

At a glance

  • 10–99 Citations
  • 1–9 Posted citations
  • Yes 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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