Pemco, Inc. - Oct. 25, 2016
Issue Date
Oct 25, 2016
Region
Central
Category
Device
$117.00
Contact Name
William J. Koteles
Contact Title
President
Address 1
5663 Brecksville Rd.
City
Independence
State
OH
Zip/Postal Code
44131
Country
United States
Inspection Range
Oct 03, 2016 - Oct 25, 2016
Pages
4
First Observation
A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the correction or removal.
Investigator(s): Benjamin J. Dastoli