Inspection Q&A
-
Asked October 8th, 2009
100% inspection refers to the correctness of the label. Specifically, as highlighted in the FDA web site (http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm095452.htm), the FDA’s current good manufacturing practice (cGMP) regulations require that “special control procedures be instituted if cut labeling is used in packaging and labeling operations.”
“One of these procedures requires the use of “appropriate electronic or electromechanical equipment to conduct a 100-percent examination for correct labeling during or after completion of finishing operations” (Sec. 211.122(g)(2))”.



