FDA 483 - Premier Laboratory, LLC - May 14, 2025

From May 12 to 14, 2025, the FDA inspected Premier Laboratory, LLC, a contract testing facility located in Longmont, Colorado. The inspection was conducted under the authority of the Federal Food, Drug, and Cosmetic Act to assess the firm’s compliance with Current Good Manufacturing Practices (CGMP). The investigators identified several critical deficiencies in the laboratory's quality systems.

Primary violations included inadequate management of deviations and corrective and preventive actions (CAPAs). The firm failed to notify clients of testing errors promptly, lacked procedures to monitor trends in failed tests, and maintained disorganized logbooks with non-chronological entries. Quality oversight was significantly lacking, as evidenced by uncontrolled work instructions that could be changed by operators without quality department approval. Additionally, the laboratory failed to ensure that staff completed required CGMP training, neglected to qualify suppliers of critical materials, and failed to monitor or qualify the refrigerators and freezers used to store sensitive samples and reagents.

While this report reflects preliminary observations and not a final agency determination, Premier Laboratory is required to respond. The firm must provide the FDA with a detailed plan for corrective actions to address these systemic failures in documentation, oversight, and equipment management to ensure the integrity of its testing services.