ZS Pharma, Inc. - Jan. 30, 2017
Issue Date
Jan 30, 2017
Region
Southwest
Category
Drug
$117.00
Contact Name
John S. Strokis
Contact Title
Head of Quality
Address 1
508 Wrangler Dr.
Address 2
Ste. 100
City
Coppell
State
TX
Zip/Postal Code
75019
Country
United States
Inspection Range
Jan 18, 2017 - Jan 30, 2017
Pages
11
First Observation
Process validation procedures do not ensure the integrity of process validation, and the quality
unit does not retain the authority to accept or reject batches conducted in accordance with process validation.
Investigator(s): Massoud Motamed and H.L. Jamillah Selby