FDA 483 - Brown Precision, Inc. - September 23, 2022

Brown Precision, Inc., a medical device manufacturer in Huntsville, AL, was cited with six observations during an FDA inspection from September 19-23, 2022. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for corrective and preventive actions, nonconforming product control, complaint handling, equipment maintenance, supplier management, and process validation. These issues indicate a systemic lack of established and implemented quality system procedures.