FDA WARNING_LETTER - Facet Technologies, LLC - March 30, 2011

An FDA inspection of Facet Technologies, LLC, conducted from March 9-30, 2011, at their McDonough, GA facility, revealed significant violations of the Quality System (QS) regulations (21 CFR Part 820) for their blood lancets and lancing devices. These devices were deemed adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements. A Form FDA 483 was issued, and the firm's May 6, 2011, response will be evaluated.

Key violations include: 1) Failure to validate processes where results cannot be fully verified, such as mold and housing press validations with out-of-specification process capabilities (Cpk) that were not investigated (21 CFR 820.75(a)). 2) Inadequate control of nonconforming product, with lots released as 'accept as is' without investigation or rationale (21 CFR 820.90(a)). 3) Failure to conduct risk analyses for design changes, such as those made to prevent device jams (21 CFR 820.30(g)). 4) Inadequate documentation of corrective and preventive action (CAPA) activities, with several CAPAs exceeding the 90-day limit without documented rationale (21 CFR 820.100(b)).

The FDA requires prompt corrective action and a written response within fifteen working days detailing specific steps, prevention plans, documentation, and a timetable for completion. Failure to comply may result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and certificates to foreign governments.