Diamond Orthotic Laboratory - Nov. 16, 2023
Issue Date
Nov 16, 2023
Region
Pacific
Category
Device
$117.00
Contact Name
Matthew M. Rago
Contact Title
Director of Operations
Address 1
7859 El Cajon Blvd.
City
La Mesa
State
CA
Zip/Postal Code
91942-0602
Inspection Range
Nov 13, 2023 - Nov 16, 2023
Pages
5
First Observation
Specifically, your firm did not follow the material control procedure titled: PA2200 Material Controls, Doc#: MS-001, Rev: 01, Effective date: 9/01/2022, to manage the ... nylon raw material for storage and manufacturing Diamond Digital Sleep Orthotic (DDSO) device.
Investigator(s): Linda Galindo and Juanj N. Wu