Health-Chem Acquisitions, LLC - Feb. 20, 2019
Issue Date
Feb 20, 2019
Region
Southeast
Category
Device
$117.00
Contact Name
Marisol Avila
Contact Title
Senior QA Manager
Address 1
3341 S.W. 15th St.
City
Pompano Beach
State
FL
Zip/Postal Code
33069-4808
Country
United States
Inspection Range
Jan 17, 2019 - Feb 20, 2019
Pages
4
First Observation
The organizational structure has not been adequately established and maintained to ensure that devices are designed in accordance with 21 CFR 820.
Investigator(s): Dianiris C. Ayala