American Antibiotics, Inc. - March 28, 2013
Issue Date
Mar 28, 2013
Region
Central
Category
Drug
$117.00
Address 1
6110 Robinwood Rd.
City
Baltimore
State
MD
Zip/Postal Code
21225
Country
US
Inspection Range
Mar 04, 2013 - Mar 28, 2013
Pages
5
First Observation
Major changes made to the drug product specifications provided in the approved application were not submitted to the agency for approval prior to distribution of the product.
Investigator(s): Rachel C. Harrington, Emily Leongini, and Chiang Syin