Brookfield Medical/Surgical FDA-483

FDA has released the form FDA-483 issued following a 4/22-5/10 inspection at the Brookfield Medical/Surgical Supplies outsourcing facility in Brookfield, CT. The four inspection observations in the form were:

• failure to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile
• failure to follow written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product;
• failure to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess; and
• failure to have the container of the facility’s drug products include information required by section 503(a)(10)(B) of the Federal Food, Drug, and Cosmetic Act.