BioSpectra, Inc. - March 5, 2015
Issue Date
Mar 05, 2015
Region
Central
Category
Drug
$117.00
Contact Name
Dora E. Meissner
Contact Title
Director of Regulatory Affairs
Address 1
10 Majestic Way
City
Bangor
State
PA
Zip/Postal Code
18013
Country
United States
Inspection Range
Mar 02, 2015 - Mar 05, 2015
Pages
2
First Observation
The qualification of equipment used in the production of Potassium Bromide API is deficient.
Investigator(s): Michael L. Casner, James M. Mason, and Deborah J. Parris