Orca1

FDA inspection

Schoelly-OPTIX OOD: FDA inspection ending Aug 4, 2022

FDA inspection 1178208 · No Action Indicated (NAI) · Panagyurishte

Key facts

Inspection ID 1178208
Firm Schoelly-OPTIX OOD
FEI number 3006149253
Address Krastyo Geshanov 30
City Panagyurishte
Fiscal year 2022
Inspection end date Aug 4, 2022
Classification No Action Indicated (NAI)
Project area Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices
Product type Devices

At a glance

  • None Citations
  • None 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.

Other inspections at this establishment

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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