Spacelabs Healthcare Incorporated – FDA Warning Letter, May 9, 2008

This FDA Warning Letter, dated November 3, 2008, was issued to Spacelabs Healthcare Incorporated following an inspection from April to May 2008. The inspection revealed that the firm's patient monitors and telemetry equipment are adulterated under section 501(h) of the Act, as manufacturing methods and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820). Additionally, devices are misbranded under section 502(t)(2) due to failures in Medical Device Reporting (MDR) as per 21 CFR Part 803. Key QS violations include inadequate procedures for complaint review and evaluation (21 CFR 820.198(a)), lack of complaint investigation records (21 CFR 820.198(e)), failure to implement and record CAPA changes (21 CFR 820.100(a)(5)), absence of preventive action procedures (21 CFR 820.100(a)), and inadequate quality audit procedures (21 CFR 820.22). MDR violations include failure to submit MDRs within 30 days for deaths or serious injuries (21 CFR 803.50(a)(1)) and for malfunctions likely to cause death or serious injury if recurring (21 CFR 803.50(a)(2)). The firm's responses, including CAPA reports and revised procedures, were deemed inadequate as evidence of implementation was lacking. The FDA requires prompt corrective action within fifteen working days, including documentation of implemented changes and plans to prevent recurrence. Failure to comply may result in regulatory actions such as seizure, injunction, civil penalties, impact on federal contracts, and delays in premarket submissions or Certificates to Foreign Governments. The letter emphasizes that the listed violations are not exhaustive and the firm must investigate and correct all underlying issues.