FDA WARNING_LETTER - Hillestad Pharmaceuticals USA, Inc. - July 27, 2012

On July 25-27, 2012, an FDA inspection of Hillestad Pharmaceuticals USA, Inc. in Woodruff, Wisconsin, revealed significant violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their products adulterated.

Key violations include: 1. **Inadequate Identity Testing (21 CFR 111.75(h)(1)):** The firm used (b)(4) for identity testing without confirming the initial lot used as a reference standard. Their established Hit Quality Index (HQI) specification of at least (b)(4) was found to be too broad, allowing multiple possible matches. They also failed to demonstrate (b)(4) as an appropriate test for probiotic species. The company's response was inadequate due to a lack of documented specific corrective steps.

2. **Failure to Verify Finished Product Specifications (21 CFR 111.75(c)):** The firm did not adequately verify finished product specifications for identity, purity, strength, and composition. Verification was "based on input" (operator adding ingredients), which is insufficient. For products like Iron Tone Plus and Folic Acid Tablets, documentation for the basis of selected specifications (e.g., Vitamin C ensuring Iron and Vitamin E specifications) was lacking. The response regarding discontinued Acidophilus product and new testing was inadequate due to missing specifications and testing details. A submitted blending