RenatiLabs, Inc. - Aug. 12, 2022
Issue Date
Aug 12, 2022
Region
Central
Category
Device
$117.00
Contact Name
Leonid Macheret
Contact Title
CEO
Address 1
1368 Cox Ave.
City
Erlanger
State
KY
Zip/Postal Code
41018-1002
Inspection Range
Aug 02, 2022 - Aug 12, 2022
Pages
5
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Investigator(s): Nisha C. Patel and Jennifer L. Sheehan