FDA 483 - Brookfield Medical/Surgical Supplies, Inc. - April 09, 2015

This FDA Form 483 details numerous deficiencies observed during an inspection. The facility manufactures sterile drug products, including Methylprednisolone Acetate Suspension injection, Triamcinolone Acetonide Suspension injection, and Betamethasone Sodium Phosphate Solution injection, which are preservative-free and have a 6-month room temperature use-by date.

Key violations include: - Failure to thoroughly review unexplained discrepancies and out-of-specification batches, lacking data to support consistent assay for vials with differing solids height (e.g., Methylprednisolone Acetate 40mg/mL PF Lot 09115EA). - Inadequate recording of reasons for rejected/discarded vials on production records (e.g., Betamethasone Sodium Phosphate PF Lot 010815). - Lack of validation for sterilization processes for drug products, manufacturing utensils (e.g., capper, decapper), and packaging materials (e.g., caps). - Absence of validation for depyrogenation processes for manufacturing utensils, including lack of expiration dates or a first-in, first-out system for depyrogenated stock. - Quality control unit responsibilities and procedures are not in writing and fully followed; drafted procedures are not approved by quality, and procedures for complaints, adverse drug events, and vendor qualification are missing. - Deficiencies in procedures to prevent microbiological contamination, including poor aseptic techniques (e.g., reopening bags, improper