Cerovene, Inc. - May 4, 2015
Issue Date
May 04, 2015
Region
Northeast
Category
Drug
$117.00
Contact Name
Manish S. Shah
Contact Title
President
Address 1
612 Corporate Way
Address 2
Ste. 10
City
Valley Cottage
State
NY
Zip/Postal Code
10989-2027
Country
United States
Inspection Range
Apr 21, 2015 - May 04, 2015
Pages
2
First Observation
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate statistical quality control critiera as a condition for their approval and release.
Investigator(s): Mindy M. Chou and Helen B. Ricalde