FDA 483 - Elite Laboratories Inc. - August 01, 2025

Elite Laboratories Inc. in Northvale, NJ, was inspected from July 21 to August 1, 2025, and received a Form 483 with six observations. The inspection revealed significant deficiencies in laboratory controls, including inadequate OOS investigations and incomplete data records, as well as issues with method validation. Furthermore, the firm lacked adequate written procedures for production and process controls, failed to properly validate manufacturing processes, and had deficiencies in equipment cleaning procedures.