Hyaluron, Inc. - June 12, 2009
Issue Date
Jun 12, 2009
Region
Northeast
Category
Drug
$117.00
Address 1
99 S. Bedford St.
Address 2
Suite 2
City
Burlington
State
MA
Zip/Postal Code
01803-5153
Country
US
Inspection Range
Jun 08, 2009 - Jun 12, 2009
Pages
2
First Observation
The firm failed to perform Performance Qualification (PQ) for their systems. Firm does not have established emergency procedure for stability chamber malfunction, such as unexpected temperature and/or humidity changes.
Investigator(s): Valentino Fiorella, Paraluman S. Leonin, and Kenneth H. Williams