FDA WARNING_LETTER - International Immuno-Diagnostics - January 03, 2011

On December 8, 2010, through January 3, 2011, an FDA inspection of International Immuno-Diagnostics in Foster City, California, revealed the firm manufactures in-vitro diagnostic reagents (IVDs) that are adulterated and misbranded.

The devices are adulterated because the firm lacks approved Premarket Approval (PMA) applications or Investigational Device Exemptions (IDE). They are misbranded due to failure to submit 510(k) premarket notifications.

Despite being labeled "For Research Use Only" (RUO), products like the Thyroid Stimulating Hormone (TSH) Enzyme Immunoassay (EIA) Test Kit and Hepatitis Delta Virus (HDV Ab) Test Kit are promoted and intended for clinical diagnostic use, as evidenced by product inserts describing clinical utility and their listing under "EIA Diagnostic Tests" in the product catalog. This violates 21 CFR 809.10(c)(2)(i) regarding RUO labeling.

Additionally, the firm failed to fulfill annual establishment registration and device listing requirements for fiscal year 2011, as mandated by section 510 of the Act, rendering all devices misbranded.

FDA requests the firm immediately cease marketing, promoting, and distributing all IVD products lacking FDA approval or clearance. A written response within 15 working days is required, detailing corrective actions, prevention plans, a timetable for implementation, and plans for