FDA WARNING_LETTER - Datascope Corp. - October 03, 2018

The FDA issued a Warning Letter to Datascope Corporation following an inspection from July 30, 2018, to October 3, 2018, at their Mahwah, NJ facility. The inspection identified that Datascope, a manufacturer of intra-aortic balloon pumps (IABPs) and Cardiosave IAB pumps, produced adulterated devices, as their manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to perform design validation (21 CFR 820.30(g)):** Specifically, for Change Notices 156251 and 163569 regarding the top protection cover installation, no design validation was performed to ensure conformity to user needs and intended uses, or to mitigate potential hazards. The firm also failed to provide documentation of dielectric strength and leakage current tests after the top cover installation. 2. **Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)):** The firm failed to identify all actions needed to correct and prevent recurrence of nonconforming products. Examples included an unvalidated welding process from a supplier and a CAPA (CRF-MAH-2017-009) for battery failures that was closed without verifying the effectiveness of implemented