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Gemini Pharmaceuticals, Inc. - June 1, 2011
Issue Date
Jun 01, 2011
Region
Northeast
Category
Drug
$117.00
Address 1
87 Modular Ave.
City
Commack
State
NY
Zip/Postal Code
11725-5718
Country
US
Inspection Range
May 25, 2011 - Jun 01, 2011
Pages
2
First Observation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Alice S. Tsao