LTS Lohmann Therapy Systems Corp. - June 11, 2019
Issue Date
Jun 11, 2019
Region
Central
Category
Drug
$117.00
Contact Name
Joachim Franke
Contact Title
CEO
Address 1
21 Henderson Dr.
City
West Caldwell
State
NJ
Zip/Postal Code
07006-6607
Country
United States
Inspection Range
Jun 04, 2019 - Jun 11, 2019
Pages
3
First Observation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Lata C. Mathew and Emmanuel J. Ramos