FDA inspection

Biofrontera Pharma GmbH: FDA inspection ending May 5, 2016

FDA inspection 969002 · Leverkusen

Key facts

Inspection ID	969002
Firm	Biofrontera Pharma GmbH
FEI number	3011764519
Address	Hemmelrather Weg 201
City	Leverkusen
Fiscal year	2016
Inspection end date	May 5, 2016
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\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: 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.

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

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