Stat Rx 1A.

Lack of test data or scientific 10/09/2012 CGMP/Finished

USA evaluation to demonstrate that Pharmaceuticals/Adulterated/Misbranded
repackaged product will be stable
during assigned expiration dates.
1B. Response deficiency:
Inadequate response. Lack of
stability program. Repackaging of
approved drugs for resale are
considered drug manufacturing
operations and therefore subjected
to CGMP.

Golden Failure to conduct an adequate 04/26/2011 CGMP for Finished

State comparison to determine whether Pharmaceuticals/Adulterated
Medical firm's container closure ia as
Supply, protective as original
Inc. manufacturer’s container closure
despite use of the manufacture’s
original expiration date. Failure to
establish specifications for the new
container closure.