FDA 483 - Highland Industries,Inc. - July 25, 2019

Highland Industries, Inc. in Cheraw, SC, a contract manufacturer of medical devices, was cited with seven observations during an FDA inspection. The inspection revealed significant deficiencies across its quality system, particularly concerning process validation, documentation, device acceptance procedures, sampling plans, device history records, equipment maintenance, and the overall quality plan. These issues indicate a lack of adequate controls to ensure medical devices are manufactured according to specifications and regulatory requirements.