Western Herb Products, Inc. – FDA Warning Letter, May 12, 2021

The FDA inspected Dr. Summerland's dietary supplement facility in Index, Washington, on May 3, 4, and 12, 2021, identifying serious violations of 21 CFR Part 111 (CGMP for dietary supplements). These violations render the products adulterated under 21 U.S.C. § 342(g)(1). Additionally, the Wormwood/Aloes dietary supplement is misbranded under 21 U.S.C. § 343.

Key violations include: 1. **Failure to establish required specifications (21 CFR 111.70(a))**: Lacked written specifications for finished dietary supplements, including identity, purity, strength, composition, and contamination limits for components (e.g., Wormwood/Aloes lot #06821-6) and finished products. In-process specifications were also absent. Revised specifications submitted were deemed inadequate. 2. **Failure to prepare and follow Master Manufacturing Records (MMRs) (21 CFR 111.205(a), 111.210)**: The MMR for Wormwood/Aloes lacked crucial information such as strength/concentration, complete component lists, accurate weights/measures, theoretical yield, packaging descriptions, and detailed manufacturing instructions. Revised MMRs were also inadequate. 3. **Failure to prepare Batch Production