Orca1

FDA inspection

Aesculap Inc: FDA inspection ending Oct 30, 2019

FDA inspection 1109476 · Voluntary Action Indicated (VAI) · Hazelwood, MO

Key facts

Inspection ID 1109476
Firm Aesculap Inc
FEI number 3003587896
Address 615 Lambert Pointe Dr
City Hazelwood
State MO
ZIP 63042-2697
Fiscal year 2020
Inspection end date Oct 30, 2019
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Med Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Compliance: Medical Devices|Human Cellular, Tissue and Gene Therapies|Human Cellular, Tissue, and Gene Therapies|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices
Product type Biologics, Devices, Drugs

At a glance

  • None 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.

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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