BioSculptor Corp. - March 13, 2020
Issue Date
Mar 13, 2020
Region
Southeast
Category
Device
$117.00
Contact Name
Mark J. Mazloff
Contact Title
President
Address 1
2480 W. 82nd St.
Address 2
Unit 1
City
Hialeah
State
FL
Zip/Postal Code
33016-2735
Country
United States
Inspection Range
Mar 11, 2020 - Mar 13, 2020
Pages
6
First Observation
Production processes were not developed, controlled and monitored to ensure that a device conforms to its specifications.
Investigator(s): Karen M. Rodriguez