FDA WARNING_LETTER - Victus, Inc. - April 22, 2009

The FDA issued a Warning Letter to Victus, Inc. following an inspection from April 20-22, 2009, at their Miami, Florida facility. The firm, a medical device specification developer of sterile IV infusion devices, was found to have adulterated devices under Section 501(h) of the Act, as their manufacturing, packing, storage, or installation methods did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Specific violations included the failure to establish and maintain procedures for evaluating complaints to determine Medical Device Reporting (MDR) requirements (21 CFR 820.198(a)(3)), and the failure to conduct quality audits by independent individuals, covering all major quality criteria like design controls, MDR, and corrections/removals (21 CFR 820.22). The firm's response to the audit observation was deemed adequate.

Furthermore, several IV Administration Sets were deemed adulterated under Section 501(f)(1)(B) due to the absence of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. These devices were also misbranded under Section 502(o) for failing to notify the agency of intent to introduce them into commercial distribution via a 510(k) submission, specifically after uncleared changes in material and the addition of new components.

Victus, Inc. was instructed to take prompt corrective action and respond within fifteen working days, detailing steps taken, prevention plans, and a timetable. Failure to comply could lead to regulatory actions such as seizure, injunction, or civil money penalties, and impact federal contracts. The FDA also expressed concerns about the safety and effectiveness of the adulterated/misbranded devices and required a report within 10 days if a voluntary correction or removal is initiated.