AmbioPharm, Inc. - Feb. 9, 2023
Issue Date
Feb 09, 2023
Region
Southeast
Category
Drug
$117.00
Contact Name
Tim Nieters
Contact Title
CEO
Address 1
1024 Dittman Ct.
City
Beech Island
State
SC
Zip/Postal Code
29842-9404
Inspection Range
Feb 01, 2023 - Feb 09, 2023
Pages
5
First Observation
Investigations conducted by your QC laboratory on out-of specification results repeatedly determined that the results obtained were invalid and re-tested samples to achieve the chromatographic profile and expected resolution for the assay and impurity tests for ... drug substance, and ... drug product, analyzed according to test methods.
Investigator(s): Libia Lugo