FDA inspection

Bio Gen Technologies, Inc: FDA inspection ending Aug 16, 2024

FDA inspection 1247229 · Skaneateles, NY

Key facts

Inspection ID 1247229
Firm Bio Gen Technologies, Inc
FEI number 3008140960
Address 2433 Wave Way
City Skaneateles
State NY
ZIP 13152-9670
Fiscal year 2024
Inspection end date Aug 16, 2024
Project area Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Compliance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices|Postmarket Assurance: Medical Devices
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 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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