FDA 483 - HF Acquisition Co LLC dba HealthFirst - June 26, 2025

During an inspection conducted by the Food and Drug Administration (FDA) from June 24 to June 26, 2025, observations were made at an unnamed firm regarding its quality system. The inspection, performed under the Federal Food, Drug and Cosmetic Act, specifically Section 704(b), identified instances where the responsibilities and procedures applicable to the quality control unit were not fully followed. Key issues included a lack of documented control over essential batch record documents. For example, the "HFP 054 F-01, Label Issuance and Reconciliation Form" was accessed and printed by the printing team directly from a shared system, indicating inadequate control over master forms. Additionally, the "RETURNS QUARANTINE LOGBOOK," which tracks returned drug products, was found to be composed of single, uncontrolled, unbound, and non-sequential sheets, lacking necessary Quality signatures upon issuance. These observations highlight deficiencies in the firm's document management and quality assurance protocols. The firm is expected to address these findings by discussing any objections or implementing corrective actions for FDA review.