FDA 483 - Brookfield Medical/Surgical Supplies, Inc. - April 18, 2017

This FDA Form 483 details observations from an inspection, citing failures in quality control and aseptic processing at a facility manufacturing Betamethasone Sodium Phosphate, Methylprednisolone Acetate, and Triamcinolone Acetonide for Injection.

A primary violation is the failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. Specifically, two lots of Betamethasone Sodium Phosphate PF 6mg/mL were rejected due to low potency (89.7%, 89.01%). The firm's corrective action involved changing a component, but the impact on potency loss, degradation, impurities, and impurity limits was not evaluated. This is a repeat observation from a 2015 FDA-483, and the firm continues to manufacture and release these products.

Additionally, the firm failed to evaluate the impact of a component change on Methylprednisolone Acetate and Triamcinolone Acetonide Suspension for Injection. Two lots of Triamcinolone Acetonide 40mg/mL failed potency (119.7%/115.4%, 121.3%), with investigations failing to assess the component's impact. A Methylprednisolone Acetate 40mg/mL lot also failed potency (110.49%) due to a component issue, the impact of which remains unassessed.

The firm also lacks rationale for not investigating lots manufactured before and after