FDA 483 - HF Acquisition Co LLC - February 09, 2018

HF Acquisition Co. LLC in Mountlake Terrace, WA, a drug/device repackager and relabeler, was cited with two observations during an FDA inspection. The inspection revealed a lack of strict control over labeling operations, including issues with label reconciliation and deficient standard operating procedures. Additionally, the firm's procedures for handling drug product complaints were found to be inadequate, with a specific instance where a shipping error was categorized as "unconfirmed" without proper corrective action or retraining.