Diagnostics Firm Cited for Not Following Production Procedures

Nanogen’s point-of-care division failed to ensure its diagnostic tests met specifications by not following its own written production procedures in the presence of an FDA investigator, according to a warning letter.

The investigator made the observation during an inspection in February at Nanogen’s Toronto facility. The observation concerned the production of gold conjugate, according to the warning letter, a material used for the company’s cardiac diagnostic tests.

The letter, which was posted on the FDA’s website in October, cited Nanogen’s manufacturing operations for its Cardiac STATus, Decision Point and i-Lynx diagnostic tests and devices.

Procedures for controlling nonconforming product or product components were cited by the FDA. Production lots of an unidentified monoclonal antibody, used in the Cardiac STATus Myoglobin, Triponin I and CK/MB Tandem Test or Decision Point Myoglobin, Triponin I and CK/MB, did not meet specifications, the FDA said.

The company initiated a nonconformance report (NCR), a corrective action, for the out-of-specification result during the inspection. Although the FDA acknowledged that fact, it said there was no evaluation made for the corrective action itself in the report. “Completing an NCR does not resolve the issue; it is merely a correction,” the FDA said.

The company told GMP it is working to resolve the issues. The warning letter can be accessed at www.fda.gov/foi/warning_letters/s6519c.pdf.