Fougera Pharmaceuticals, Inc. - May 29, 2018
Issue Date
May 29, 2018
Region
Northeast
Category
Drug
$117.00
Contact Name
Evelyn Marchany Garcia
Contact Title
VP and Site Head Tech Ops
Address 1
55 Cantiague Rock Rd.
City
Hicksville
State
NY
Zip/Postal Code
11801-1126
Country
United States
Inspection Range
May 15, 2018 - May 29, 2018
Pages
2
First Observation
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
Investigator(s): Jose O. Hernandez