Sonar Products - June 21, 2010
Issue Date
Jun 21, 2010
Region
Central
Category
Drug
$117.00
Address 1
609 Industrial Rd.
City
Carlstadt
State
NJ
Zip/Postal Code
07072-1611
Country
US
Inspection Range
Jun 14, 2010 - Jun 21, 2010
Pages
2
First Observation
The responsibilities and procedures applicable to the quality control unit are not in writing.
Specifically, SOP 011-35, General Responsibilities of Quality Assurance and Quality Control, fails to include the quality unit's authority to approve and reject batches manufactured.' Further, individuals reviewing and approving product release are also responsible for reviewing and approving quality control and manufacturing records. For example, we observed Batch 5994, Lidocaine 3.0% Cream was released by personnel not within the quality unit; this individual also reviewed and approved the associated manufacturing and quality control records.
Investigator(s): Frederick Razzaghi and Addam S. Reynolds