Cosette Pharmaceuticals NC Laboratories, LLC - July 21, 2023
Issue Date
Jul 21, 2023
Region
Southeast
Category
Drug
$117.00
Contact Name
Greg M. Sherwood
Contact Title
Senior Vice President of Operations
Address 1
1877 Kawai Rd.
City
Lincolnton
State
NC
Zip/Postal Code
28092-5905
Inspection Range
Jul 17, 2023 - Jul 21, 2023
Pages
3
First Observation
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components and drug product containers pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.
Investigator(s): Harshal J. Desai, Regan T. Harp, and Megan T. Ziegler