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. The facility manufactures Betamethasone Sodium Phosphate, Methylprednisolone Acetate, and Triamcinolone Acetonide for Injection.

**Key Violations and Observations:**

1. **Inadequate Investigation of Discrepancies (Repeat Observation from 2015 FDA-483):** * Failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. * **Betamethasone Sodium Phosphate PF 6mg/mL:** Two lots (120314MB, 110314MA) were rejected due to low potency (89.7%, 89.01%). Corrective actions involved (b)(4) and (b)(4), but the firm has not evaluated the effect of this change on potency loss, degradation, impurities, or established scientifically justified impurity limits. The firm continues to manufacture, (b)(4), and release this product. * **Methylprednisolone Acetate and Triamcinolone Acetonide Suspension for Injection:** The firm has not evaluated the impact of (b)(4). * **Triamcinolone Acetonide 40mg/mL Suspension for Injection:** Two lots (012116MB, 072616EB) failed potency (