Glottal Enterprises, Inc. - Oct. 9, 2013
Issue Date
Oct 09, 2013
Region
Northeast
Category
Device
$117.00
Contact Name
Martin NMI Rothenberg
Contact Title
President
Address 1
1201 E Fayette St.
Address 2
Ste 15
City
Syracuse
State
NY
Zip/Postal Code
13210-1988
Country
United States
Inspection Range
Oct 02, 2013 - Oct 09, 2013
Pages
3
First Observation
The design history file was not established, does not demonstrate that the design was developed following the approved design plan, and does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Nicholas C. Mendiola