Numerous quality management system lapses, including inadequate process control procedures and failure to initiate corrective and preventive actions were uncovered during a Feb. 25-27 FDA inspection of New Life Diagnostics’ Carlsbad, California plant.
The firm, which develops and manufactures a range of in vitro diagnostics for laboratory use, had not established quality control procedures that describe process controls to ensure conformance to specifications, the 483 said.
Specifically, the IVD maker had not established quality control testing and product retention procedures for panel characterization and qualification and documentation of samples used in manufacturing and testing its ELISA IVDs.
Also lacking were procedures to ensure that equipment was routinely calibrated, inspected, checked and maintained.
