BAMF Health, Inc. - July 1, 2022
Issue Date
Jul 01, 2022
Region
Central
Category
Drug
$117.00
Contact Name
Matthew H. DeLong
Contact Title
Vice President
Address 1
109 Michigan St. NW
Address 2
Ste. 110
City
Grand Rapids
State
MI
Zip/Postal Code
49503
Inspection Range
Jun 27, 2022 - Jul 01, 2022
Pages
2
First Observation
Your firm lacks adequate production and process controls to ensure consistent production of a PET drug that meets the applicable standards of identity, strength, quality, and purity.
Investigator(s): Courtney E. Hillier and Norman Starks