Brookfield Medical Hit with GMP Untitled Letter

FDA has released a recent untitled letter that was sent to Brookfield Medical/Surgical Supplies, an outsourcing facility in Brookfield, CT, due to GMP issues cited during a May inspection. The four inspection observations in the letter 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.