Baxter Healthcare Corp. - Feb. 9, 2024
Issue Date
Feb 09, 2024
Region
Southeast
Category
Drug
$117.00
Contact Name
Timothy J. Marini
Contact Title
VP, Operations - Medical Products and Therapies
Address 1
65 Pitts Station Rd.
City
Marion
State
NC
Zip/Postal Code
28752-7925
Inspection Range
Jan 29, 2024 - Feb 09, 2024
Pages
11
First Observation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Investigator(s): Veronica Fuentes, Susan Hadman, Libia Lugo, and Demario L. Walls