FDA 483 - Optum Compounding Services, LLC - August 13, 2021

An FDA inspection of Optum Compounding Services, LLC, an outsourcing facility located at 24416 N 19th Ave, Phoenix, AZ, was conducted from August 2-13, 2021. The inspection identified three observations.

Observation 1 notes that the quality control unit lacks responsibility to approve and reject procedures or specifications impacting drug product identity, strength, quality, and purity. Specifically, the visual inspection program for syringes is inadequate. For example, Bevacizumab lot #138-20213103@12 had initial and re-inspections yielding high rejectable defect rates (b)(4)% and (b)(4)% respectively, for issues like fibers, particles, and barrel/plunger defects, yet was released. Similarly, Bevacizumab lot #138-20211901@19 failed an AQL inspection, underwent re-inspection, and was subsequently released. Furthermore, no limits or specifications for typical rejection rates during 100% visual inspection, or for categories of defects (critical, major, minor), have been established. The current defect specification is only for total rejected syringes per batch. Release testing for syringes is also inadequate, as evidenced by the release of a syringe lot that later resulted in numerous rejections due to intrinsic white particles in Bevacizumab lot #138-20213103@