Boiron, Inc. - Oct. 25, 2021
Issue Date
Oct 25, 2021
Region
Central
Category
Drug
$117.00
Contact Name
Mark Land
Contact Title
Vice President of Government & Regulatory Affairs
Address 1
6 Campus Blvd.
City
Newtown Square
State
PA
Zip/Postal Code
19073-3200
Country
United States
Inspection Range
Oct 04, 2021 - Oct 25, 2021
Pages
7
First Observation
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Investigator(s): Brandy N. Lepage and Anastasia M. Shields