SOFIE Co. - Jan. 15, 2019
Issue Date
Jan 15, 2019
Region
Southwest
Category
Drug
$117.00
Contact Name
Adrryl Addison
Contact Title
Nuclear Pharmacist/Facility Manager
Address 1
4447 Brass Way
City
Dallas
State
TX
Zip/Postal Code
75236-2001
Country
United States
Inspection Range
Jan 09, 2019 - Jan 15, 2019
Pages
3
First Observation
A sample for sterility testing was held longer than ..., but you did not demonstrate that the longer period did not adversely affect the sample and that the test results obtained were equivalent to test results that would have been obtained if the test had been started within the ... period.
Investigator(s): Patty Kaewussdangkul