FDA 483 - AVEVA Drug Delivery Systems, Inc. - September 01, 2023

An FDA inspection was conducted at AVEVA Drug Delivery Systems, Inc., a drug manufacturer in Miramar, FL, from August 28 to September 1, 2023. The inspection, carried out under the authority of the Federal Food, Drug, and Cosmetic Act, identified two key observations related to facility and operational controls.

The first observation noted a significant lapse in the security of packaging and labeling materials. Investigators found that access to the storage area for labels was not limited to authorized personnel due to a broken gate, a condition that had reportedly existed for several months without a corrective action plan. This raises concerns about potential unauthorized access or mislabeling.

Secondly, issues were identified within the facility's washing and toilet amenities. On multiple occasions, hot water was either unavailable or not readily present in bathrooms located near both manufacturing/production and laboratory areas. Maintaining appropriate hygiene facilities with adequate hot water is essential for sanitation and preventing contamination in a drug manufacturing environment.

While an FDA 483 document serves as an observation report and not a final determination of compliance, AVEVA Drug Delivery Systems, Inc. is expected to promptly address these deficiencies by implementing robust corrective and preventive actions to ensure full adherence to regulatory requirements and maintain appropriate control over their operations.