Gulbrandsen Technologies - Aug. 26, 2015
Issue Date
Aug 26, 2015
Region
Southeast
Category
Drug
$117.00
Contact Name
Erik H. Ebersole
Contact Title
Plant and General Manager
Address 1
183 Gulbrandsen Rd.
City
Orangeburg
State
SC
Zip/Postal Code
29115
Country
United States
Inspection Range
Aug 24, 2015 - Aug 26, 2015
Pages
2
First Observation
The firm failed to perform process validation for an active pharmaceutical ingredient (API) manufacturing process.
Investigator(s): Reba A. Gates, Jawaid Hamid, and Sharon Pratt