Anika Therapeutics, Inc. - December 16, 2009
Issue Date
Dec 16, 2009
Region
Northeast
Category
Device
$117.00
Address 1
236 W. Cummings Park
City
Woburn
State
MA
Zip/Postal Code
10801
Country
US
Inspection Range
Nov 12, 2009 - Dec 06, 2009
Pages
5
First Observation
Process controls do not provide for documented instructions, standard operating procedures (SOPs), and methods that define and control the manner of production, monitoring and control of process parameters and component and device characteristics during production or compliance with specified reference standards or codes.
Investigator(s): Brenda P. King, Allison A. Rodriguez, and Maura Rooney