Regenerative Processing Plant, LLC - June 30, 2023
Issue Date
Jun 30, 2023
Region
Southwest
Category
Drug
$117.00
Contact Name
Carl R. Harrell
Contact Title
Medical Director
Address 1
34176 Us Highway 19 N.
City
Palm Harbor
State
FL
Zip/Postal Code
34684-2144
Inspection Range
Jun 20, 2023 - Jun 30, 2023
Pages
13
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the process.
Investigator(s): Samantha J. Pinizzotto and Ivan E. Reyes