Alcami Carolinas Corporation – FDA 483, Sep 26, 2025

An FDA inspection of Alcami Carolinas Corporation, a drug manufacturer and contract testing laboratory in Wilmington, NC, was conducted from September 22-26, 2025. The inspection resulted in a Form FDA 483, documenting significant observations indicating deviations from current Good Manufacturing Practices (cGMP).

Key issues identified include deficiencies in the company's Facilities and Equipment System. Specifically, the environmental monitoring program was inadequate to verify cleaning effectiveness for potential active pharmaceutical ingredient (API) carry-over, particularly where potent and non-potent drugs are produced in shared spaces. Furthermore, analytical methods for detecting cross-contamination lacked sufficient sensitivity.

The Production System also showed non-compliance, as the firm lacked scientific justification for its raw material sampling procedure (SOP 15333.30), which failed to ensure representative sampling of incoming materials. Under the Materials System, the FDA observed a failure to establish procedures to prevent objectionable microorganisms. An operator was seen picking up tablets from the floor and subsequently handling product after only spraying gloves with sanitizer, a practice that lacked scientific rationale.

These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, highlight critical areas requiring comprehensive corrective actions from Alcami Carolinas Corporation to ensure the safety, identity, strength, quality, and purity of their drug products.