FDA 483 - Awareness Technology, Inc. - June 12, 2023

An FDA inspection of Awareness Technology, Inc. in Palm City, FL, identified significant documentation deficiencies within its manufacturing operations. The firm failed to adequately document monthly reviews of corrective and preventive actions, lacked required information in customer complaint investigation records, and did not properly establish or document equipment maintenance schedules. These observations highlight a need for improved adherence to internal procedures and regulatory record-keeping requirements.