FDA 483 - Cosmetics & Cleaners International LLC dba C&C Industries - March 26, 2026

Between March 24 and March 26, 2026, the Food and Drug Administration (FDA) conducted an inspection of Cosmetics & Cleaners International LLC, a contract manufacturer of over-the-counter products based in High Point, North Carolina. The inspection, documented on Form 483, identified a primary violation regarding the firm"s quality management systems. Specifically, the company failed to establish and implement comprehensive written procedures for annual product reviews. An evaluation of the firm’s 2025 records revealed that their standard operating procedures were insufficient as they omitted critical safety and quality assessments. The missing documentation included reviews of customer complaints, product recalls, returned or salvaged items, and stability data. Additionally, the firm did not provide assessments of products that failed to meet specifications or investigations into significant discrepancies. These observations were issued under the Federal Food, Drug, and Cosmetic Act to ensure the facility maintains sanitary and safe manufacturing conditions. Although the report is not a final determination of non-compliance, the company is required to respond. Cosmetics & Cleaners International LLC must provide a detailed plan for corrective actions or offer objections to the findings to the FDA district office. This response is necessary to ensure the firm aligns with safety standards and maintains the integrity of their drug manufacturing processes.