Spacelabs Healthcare Inc – FDA Warning Letter, Apr 2, 2014

This FDA Warning Letter, dated August 11, 2014, is an amendment to an August 5, 2014 letter, correcting a typographical error and extending the response deadline. It resulted from an inspection of a Snoqualmie, Washington firm manufacturing patient monitoring devices (e.g., Qube, Ultraview SL, ?lance Central Station) from February 12 to April 2, 2014. The inspection found the devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: CAPAs were closed without implementing corrective actions (e.g., CAPA 31920, 24340) and effectiveness was not verified/validated (e.g., CAPA 31363). 2. **Failure to control nonconforming product (21 CFR 820.90(a))**: Out-of-specification components were accepted without Nonconforming Materials Records (NMRs). 3. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: Service