ADMI - June 3, 2022
Issue Date
Jun 03, 2022
Region
Northeast
Category
Device
$117.00
Contact Name
Tanya Enigk
Contact Title
Senior Director of Compliance
Address 1
281 Sanders Creek Pkwy.
City
East Syracuse
State
NY
Zip/Postal Code
13057-1307
Inspection Range
May 26, 2022 - Jun 03, 2022
Pages
4
First Observation
Required records are not maintained at a location that is reasonably accessible to responsible officials of the manufacturer and to employees of the FDA and were not made readily available for review and copying by the FDA.
Investigator(s): Wendy M. Stone