Gold Standard Diagnostics – FDA Warning Letter, Dec 20, 2013

On April 25, 2014, the FDA issued a Warning Letter to Gold Standard Diagnostics, Inc. following an inspection from November 19 to December 20, 2013. The inspection revealed significant violations regarding the manufacturing and marketing of various infectious pathogen test kits, including those for Brucella, Influenza A, Mumps, Measles, and Toxocara canis, as well as the imported Savyon Diagnostics Bordetella pertussis kit.

The devices were deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacked approved Premarket Approval (PMA) applications or Investigational Device Exemptions (IDE). They were also misbranded under section 502(o) for failure to submit 510(k) premarket notifications.

Furthermore, the devices were adulterated under section 501(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Specific QS violations included: 1. Failure to establish procedures for design changes (21 CFR 820.30(i)), particularly for software changes, lacking documentation of verification/validation for Thunderbolt GUI software modifications. 2. Failure to establish supplier requirements (21 CFR 820.50(a)), with no documentation of design responsibilities or software validation/verification for the Thunderbolt