483sOnline Subscribe

Search By Date Issued

Search By Category

Drug
Device
Clinical

Search By Company/

Clinical Investigator

Search By Region

Search By FDA Investigator

Search By Keyword

Log in to start searching through our library of thousands of 483s, or Subscribe Now to 483sOnline.com to uncover exactly what FDA Inspectors are thinking about. It’s your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on so you can be prepared – before they show up.

Health-Chem Acquisitions, LLC - Feb. 20, 2019

Issue Date

Feb 20, 2019

Region

Southeast

Category

Device
$117.00

Health-Chem Acquisitions, LLC

Contact Name

Marisol Avila

Contact Title

Senior QA Manager

Form483 Address 1

3341 S.W. 15th St.

Form483 Address 2

Form483 City

Pompano Beach

Form483 State

FL

Form483 Postal

33069-4808

Form483 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