FDA WARNING_LETTER - Beckman Coulter Inc. - December 11, 2023

The FDA issued a Warning Letter to Ms. Montgomery, manufacturer of DxI 9000 Access Immunoassay analyzer instrument system and assays, following an inspection from November 1, 2023, to December 11, 2023. The inspection revealed that the devices are adulterated as manufacturing methods, facilities, or controls do not conform to Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to adequately establish and maintain procedures for risk analysis (21 CFR 820.30(g))**: The firm's "Product Safety Risk Management" procedure had insufficient definitions for certain severity of harm categories, leading to incorrect severity ratings for various assays' false result failure modes (e.g., HBs Ag, HBc IgM, HBc Ab, Troponin I, Digoxin). Additionally, the firm failed to use semi-quantitative ranges for occurrence ratings when data was available, deviating from their own procedures. The firm's responses were deemed inadequate, lacking proposed updates, justifications, or systemic corrective actions.

2. **Failure to adequately establish procedures for corrective and preventative actions (21 CFR 820.100(a))**: Procedures for analyzing quality data to identify nonconforming product causes were inadequate. Specifically, the "Manufacturing Non-Conformance CAPA Eligibility" procedure lacked uniform processes and clear criteria for escalating nonconformances to CAP