FDA EIR - SpecGx LLC - November 22, 2016

An FDA inspection was conducted at Mallinckrodt, Inc.'s Saint Louis, MO facility from November 16 to November 22, 2016. This abbreviated inspection, covering the Quality System and Laboratory Control System, focused on the company's manufacturing of active pharmaceutical ingredients (APIs) and finished dosage products, including Hydrocodone Bitartrate and Oral Transmucosal Fentanyl Citrate Lozenges. The inspection was carried out under the regulatory framework of Good Manufacturing Practices (GMP) for both API processes and drug manufacturing.

At the conclusion of the inspection, a single observation was issued on an FDA Form 483 to the Senior Site Director. The main violation identified was the inadequacy of laboratory control records, specifically the failure to consistently monitor and verify storage conditions for essential reference standards and resolution solutions used in API testing. This included instances of missing temperature data from a vault refrigerator storing critical reference standards, unreviewed recording charts for the same equipment, and insufficient verification of temperatures for a laboratory refrigerator holding resolution solutions.

Mallinckrodt management acknowledged the observation and committed to providing a written response within 15 business days. The company was also reminded of its overarching responsibility to comply with the Federal Food, Drug, and Cosmetic (FD&C) Act. It was noted that prior verbal observations from a 2014 inspection, concerning API manufacturing tank identification, pH meter standardization, and milling record documentation, had been successfully corrected.