FDA 483 - Brookfield Medical/Surgical Supplies, Inc. - June 28, 2017

This FDA Form 483, issued to James P. Cangelosi, Owner of Brookfield Pharmacy (FEI 3011430551) at 60 Old New Milford Rd, Suite 2B, Brookfield, CT 06804, details observations from an inspection conducted on June 20-23, 28, 2017. The firm is identified as a producer of sterile and non-sterile drug products.

Four observations were noted: 1. The firm produces intrathecal drug products (e.g., combinations of Baclofen, Clonidine, Dilaudid, Ketamine, Fentanyl, Morphine, Sufentanil, Methadone, Bupivacaine, Hydromorphone) from non-sterile bulk active ingredients without endotoxin level control, providing no assurance of final product endotoxin limits. 2. Sporicidal agent use in cleanrooms and ISO classified areas is inadequate. Cleaning and gowning procedures (SOP #4.01 and SOP 2.04) lack stipulated contact times for sporicidal agents like (b) (4) and sanitizing agents like (b) (4), contrary to manufacturer instructions. Adherence to contact times was not observed. 3. ISO-5 classified areas were not certified under dynamic conditions; specifically, uni-directional airflow was not verified via smoke studies under operational conditions for