FDA WARNING_LETTER - rhg & company inc., - September 02, 2010

On August 12, 13, 17-19 and September 1, 2, 2010, the U.S. Food and Drug Administration (FDA) inspected RHG & Company Inc., dba Vital Nutrients, located at 45 Kenneth Dooley Drive, Middletown, CT. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements (21 CFR Part 111), rendering products like PreNatal Multi-Nutrients, Garlic Extract, Milk Thistle 80%, and Vitamin D3 5000iu Capsules adulterated.

Key violations include: 1. **Failure to test finished batches for strength:** The company did not test each finished batch of Vitamin D3 5000iu (Lots 10F10, 9M34), PreNatal Multi-Nutrient (Lot 10B22), and Garlic Extract 300 mg (Lot 9K11) to verify they met strength specifications. The company's response was inadequate as it lacked documentation of current testing. 2. **Failure to establish component specifications:** The Raw Material Specification Sheet for garlic powder extract lacked a strength specification (e.g., Allicin content), despite the finished product having an Allicin strength specification. 3. **Failure to establish in-process specifications:** The Master Manufacturing Records (