FDA WARNING_LETTER - Heritage Labs International LLC - June 23, 2010

During a June 15-23, 2010 inspection, the FDA found Heritage Labs International LLC, manufacturer of In-Vitro Diagnostic Devices (IVDs), in violation of the Federal Food, Drug, and Cosmetic Act. The Appraise® Biometric Collection Tests for Hemoglobin A1c, Microalbumin, PSA, and TSH were deemed misbranded under section 502(o) for failure to submit a 510(k) premarket notification. These devices were also adulterated under section 501(f)(1)(B) due to the lack of an approved premarket approval application.

Additionally, the Appraise® Biometric Collection Tests for PSA, TSH, Microalbumin, and Lipids were misbranded under section 502(o) because they were not included in the firm's device listing during registration. The company's website also misbranded devices under Section 502(a) and 21 CFR 807.39 by displaying "FDA Registered," implying official approval.

The FDA acknowledged the firm's July 15, 2010 response to the FDA 483 regarding quality system deficiencies, but noted these were separate from the warning letter's content. The company must promptly correct all violations to avoid regulatory actions such as seizure, injunction, or civil money penalties. A written response detailing corrective actions, prevention plans, and