FDA 483 - Hawthorne Products, Inc - May 21, 2025

Hawthorne Products, Inc. in Dunkirk, IN, was inspected by the FDA from May 19-21, 2025, and received a Form 483 with 15 observations. The inspection revealed significant deficiencies across multiple areas of drug manufacturing, including a lack of written procedures for quality control, laboratory controls, equipment maintenance, and change control. The firm also failed to conduct essential finished product testing, maintain proper batch records, and ensure adequate facility and equipment calibration, indicating a broad lack of adherence to cGMP regulations.