FDA WARNING_LETTER - Pharma Tech Solutions, Inc - March 06, 2014

An FDA inspection of Pharma Tech Solutions from March 4-6, 2014, revealed that the firm's GenStrip glucose test strips, classified as medical devices, were adulterated and misbranded. The devices were found to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with the Quality System (QS) regulation (21 CFR Part 820) regarding manufacturing controls. They were also misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under Medical Device Reporting (MDR) regulations (21 CFR Part 803).

Key violations included the failure to establish and maintain procedures for corrective and preventive action (21 CFR 820.100(a)), inadequate complaint investigation records (21 CFR 820.198(e)), and the failure to develop, maintain, and implement MDR procedures (21 CFR 803.17). The firm's responses to the FDA 483 were deemed inadequate, as submitted procedures lacked evidence of implementation or effective dates, and did not fully address the deficiencies.

Pharma Tech Solutions must take prompt action to correct these violations. A written response detailing specific corrective steps, including a timetable for systemic changes and supporting documentation, is required within fifteen business days. An MDR procedure with an effective implementation date must be provided within thirty days. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments.