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
60 Baylis Rd.
City
Melville
State
NY
Zip/Postal Code
11747-3838
Country
United States
Inspection Range
May 17, 2018 - May 29, 2018
Pages
1
First Observation
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Investigator(s): Jose O. Hernandez