FDA WARNING_LETTER - Windmill Health Products, LLC - July 17, 2013

The FDA inspected Windmill Health Products, LLC, from June 18 to July 17, 2013, identifying serious violations of dietary supplement CGMP regulations (21 CFR Part 111), causing products to be adulterated under section 402(g)(1) of the Act. Additionally, products like Nutri-Betic and Glucoflex Joint Lube were promoted with therapeutic claims on labels and the website, classifying them as unapproved new drugs under sections 201(g)(1)(B) and 201(p). These products lack FDA approval (section 505(a)) and are misbranded under section 502(f)(1) due to inadequate directions for use, violating sections 301(d) and 301(a).

Specific CGMP deficiencies included: quality control personnel failing to ensure manufacturing, packaging, labeling, and holding operations meet quality standards and master manufacturing records (21 CFR 111.105), relying on insufficient Certificates of Analysis; failure to establish and follow written procedures for holding and distributing operations (21 CFR 111.453); and failure to establish and follow written procedures for product complaints (21 CFR 111.553).

The firm's responses were inadequate. As a distributor, Windmill Health Products is ultimately responsible for CGMP compliance. Prompt corrective action, including a written response within fifteen working days with documentation, is required. Non-compliance may lead to legal action, including seizure, injunction, and reinspection fees.