Biomedix, Inc. – FDA Warning Letter, Mar 4, 2013

On June 14, 2013, the FDA issued a Warning Letter to Biomedix, Inc. following an inspection from February 5 to March 4, 2013, which revealed significant violations of the Quality System (QS) regulation for their Select-3 Intravenous (IV) Administration Set. The device was deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with current good manufacturing practices (21 CFR Part 820).

Key violations include: 1. **Design Control (21 CFR 820.30):** Failure to establish and maintain procedures for design control, including identification, documentation, validation/verification, review, and approval of design changes, and maintaining a design history file. The firm's response was inadequate due to lack of objective evidence of implementation. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Inadequate CAPA system, specifically failing to analyze or investigate scrapped components to determine the cause of quality problems. The adequacy of the firm's response could not be determined, pending further revisions to their CAPA procedure. 3. **Process Validation (21 CFR 820.75(a)):** Failure to validate the sterilization process (using (b)(4)) and semi-automated