FDA WARNING_LETTER - Medical Components, Inc dba MedComp - February 12, 2015

On April 2, 2015, the FDA issued a Warning Letter to Medical Components, Inc. following an inspection from January 13 to February 12, 2015, which found their (b)(4) dialysis catheters to be adulterated under 21 U.S.C. § 351(h) due to non-conformance with Current Good Manufacturing Practice (CGMP) requirements outlined in 21 CFR Part 820 (Quality System Regulation).

Key violations included: 1. **Inadequate Documentation of Corrective and Preventive Actions (CAPA)** (21 CFR 820.100): Biological Indicator (BI) failures after ethylene oxide sterilization were not escalated to the CAPA system for root cause analysis. Two CAPAs remained open for over 410 days without root cause determination for ongoing performance issues with (b)(4) dialysis catheters, including 33 complaints for holes in (b)(4) catheters and 27 for holes in (b)(4) silicone extension tubing. Additionally, CAPAs (b)(4) were open for over 409 days without determining corrective actions to prevent sales personnel from requesting unapproved design changes, leading to 27 catheters manufactured without regulatory review or approval for a cuff elimination design modification. 2. **Lack of Process Validation** (21 CFR 820.75): The