FDA WARNING_LETTER - Express Diagnostics Int'l., Inc. - June 24, 2014

On June 16-24, 2014, an FDA inspection of Express Diagnostics International, Inc. in Blue Earth, Minnesota, revealed that the firm's drug of abuse test kits, classified as devices, were adulterated. The manufacturing, packing, storage, or installation methods, facilities, or controls did not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. **Failure to establish adequate procedures for acceptance of in-process product (21 CFR 820.80(c))**: Numerous deviations allowed product acceptance without required positive control testing. 2. **Failure to establish adequate procedures for corrective and preventive action (21 CFR 820.100(a))**: CAPA procedures were not followed, with incomplete action plans, premature closures, and missing documentation. 3. **Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a))**: Complaint handling was inconsistent, lacking proper investigation and documentation of positive control testing or raw data. 4. **Failure to establish adequate procedures for non-conforming product disposition (21 CFR 820.90(b)(1))**: Non-conformance closures occurred before product disposition, and unapproved dispositions were observed. 5