FDA 483 - Dee Cee Laboratories, Inc - August 11, 2025
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Dee Cee Laboratories, Inc. in White House, TN, was inspected and received a Form 483 with seven observations related to significant deficiencies in their quality control unit, manufacturing process validation, cleaning procedures, stability assessment, equipment qualification, annual product review, and in-process controls. The firm manufactures homeopathic drug products and demonstrated a lack of control over critical processes and documentation. These issues indicate a systemic failure to adhere to good manufacturing practices.
ID · 61f9c7ac-5466-4c62-9377-9c6f8b73af52