FDA 483 - Bella Pharmaceuticals, Inc. - August 03, 2017

An FDA inspection conducted at Bella Pharmaceuticals, Inc., an outsourcing facility in Chicago, IL, from June 10 to July 18, 2017, revealed significant deviations from regulatory requirements. The FDA Form 483 issued to Owner Michael B. Younan detailed critical observations across various operational areas. Key issues included a lack of validated aseptic filling procedures, insufficient environmental and personnel monitoring for microbiological contamination, and poor sanitization practices within sterile compounding areas. The facility exhibited structural deficiencies, such as a chipping floor in the ISO-5 area and improper seals. The company also failed to maintain adequate production records for compounded sterile drugs and lacked crucial finished product testing, including potency, endotoxin, and sterility suitability. Furthermore, control over bulk drug substances was inadequate, with expired materials available, and personnel gowning procedures were found to be deficient, leading to exposed skin during sterile compounding. Critically, drug product labels were missing mandatory information, such as statements identifying them as compounded drugs, active ingredient lists, compounding dates, and adverse event reporting details, as required for outsourcing facilities. Bella Pharmaceuticals is expected to provide a comprehensive response outlining its corrective and preventive actions to address these serious observations.