Altaire Pharmaceuticals, Inc. - Feb. 11, 2022
Issue Date
Feb 11, 2022
Category
Device
$117.00
Contact Name
Michael S. Sawaya
Contact Title
General Counsel & Vice President of Regulatory Affairs & Quality
Address 1
311 West Ln.
Address 2
P.O. Box 849
City
Aquebogue
State
NY
Zip/Postal Code
11931-0849
Country
United States
Inspection Range
Sep 14, 2021 - Feb 11, 2022
Pages
19
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Investigator(s): Bijoy Panicker, Jazmine N. Still, and Juanita P. Versace