FDA 483 - Brookfield Medical/Surgical Supplies, Inc. - April 04, 2022

The FDA Form 483 documents observations from an inspection of a facility producing Betamethasone Sodium Phosphate, (b)(4) solutions, Methylprednisolone Acetate, and Triamcinolone suspensions.

Several facility and equipment issues were noted: brownish rust-like material on a bracket in an ISO-5 laminar flow hood used for aseptic production; chipped paint on an ISO-8 Ante Room door damper, where sterile gowning, weighing, and formulation occur; and brownish stains in the unclassified Prep Room sink used for washing production equipment.

Quality system and manufacturing deficiencies include the routine use of a household cleaner for glassware and equipment without evidence of its ability to remove pharmaceutical residues or if it leaves residues. Smoke studies from 2021 for non-terminally sterilized products were inadequate, lacking full assessment of ISO-7 and ISO-5 air interactions under dynamic conditions. The firm failed to qualify (map) a refrigerator/freezer used for storing Betamethasone Sodium Phosphate, USP, and environmental monitoring media, to evaluate temperature distribution.

Critical findings relate to visual inspection: the SOP "Visual Inspection of Sterile Drug Products" and batch records lack defined release criteria for minor, major, or critical defects, impacting consistency among inspectors. Furthermore, the visual inspection test kits do not include all known defects, such as "Growth."