483sOnline Subscribe

Search By Date Issued

Search By Category

Drug
Device
Clinical

Search By Company/

Clinical Investigator

Search By Region

Search By FDA Investigator

Search By Keyword

Log in to start searching through our library of thousands of 483s, or Subscribe Now to 483sOnline.com to uncover exactly what FDA Inspectors are thinking about. It’s your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on so you can be prepared – before they show up.

Rotop Pharmaka GmbH - Dec. 9, 2018

Issue Date

Dec 09, 2018

Region

HQ

Category

Drug
$117.00

Rotop Pharmaka GmbH

Contact Name

Jens Junker

Contact Title

CEO/Managing Director

Form483 Address 1

Bautzner Landstrasse 400

Form483 Address 2

Form483 City

Dresden

Form483 State

Saxony

Form483 Postal

01328

Form483 Country

Germany

Inspection Range

Nov 19, 2018 - Dec 07, 2018

Pages

3

First Observation

Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Investigator(s): Kham Phommachanh