BD Life Sciences, Preanalytical Solutions - March 1, 2019
Issue Date
Mar 01, 2019
Region
Southeast
Category
Device
$117.00
Contact Name
Kenneth L. Lee
Contact Title
Plant Manager
Address 1
1575 Airport Rd.
City
Sumter
State
SC
Zip/Postal Code
29153-8786
Country
United States
Inspection Range
Feb 25, 2019 - Mar 01, 2019
Pages
1
First Observation
Process control procedures that describe any process controls necessary to ensure conformance to
specifications have not been adequately established.
Investigator(s): Yung W. Chan and Melanie W. Pishnery