BioMarin Pharmaceutical, Inc. - April 2, 2021
Issue Date
Apr 02, 2021
Region
Pacific
Category
Drug
$117.00
Contact Name
Erik T. Fouts
Contact Title
Vice President Novato Operations
Address 1
46 Galli Dr.
City
Novato
State
CA
Zip/Postal Code
94949
Country
United States
Inspection Range
Mar 25, 2021 - Apr 02, 2021
Pages
2
First Observation
Your firm does not have a written established procedure for requesting and shipping samples to the control laboratories for testing of cell banks, drug substance, and drug product.
Investigator(s): Hung H. Do and Uttaniti Limchumroon