FDA 483 - Brookfield Medical/Surgical Supplies, Inc. - December 21, 2018

This FDA Form 483 document, dated December 10, 2018, details significant deficiencies in the manufacturing of sterile drug products. The firm lacks written procedures for production and process controls, specifically failing to validate manufacturing processes for sterile drug products. For example, Process Validation for 3mL and 5mL Triamcinolone Acetonide Suspension 40mg/mL for Injection was incomplete, and for 5mL Methylprednisolone Acetate Suspension 40mg/mL for Injection, it had not started. The firm has manufactured numerous lots of these products without validation since January 8, 2018.

Environmental monitoring in aseptic processing areas is deficient; there is no scientific justification for not monitoring environmental conditions throughout manufacturing within the ISO 5 Laminar Flow Hood (LFH), and differential pressure of the ISO 5 LFH is not monitored during operations. The firm also failed to conduct a disinfectant efficacy study for cleaning agents used on surfaces and equipment.

Incoming Active Pharmaceutical Ingredients (APIs) for sterile drug products (Methylprednisolone Acetate, Triamcinolone Acetonide, Betamethasone Sodium) are not routinely tested for bioburden and endotoxins prior to use, with specific instances cited where products were released without these tests. Procedures to prevent microbiological contamination were not followed, as operators were observed with exposed body parts entering the ISO-5 hood and wearing non-sterile attire during cleaning.

Equipment maintenance is inadequate