FDA WARNING_LETTER - Wyldewood Cellars Inc - November 26, 2013

On October 21-November 26, 2013, the FDA inspected Wyldewood Cellars Inc.'s dietary supplement manufacturing and juice processing facility. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), rendering their dietary supplements adulterated under Section 402(g)(1) of the Federal Food Drug and Cosmetic Act.

Key violations include: 1. **Failure to prepare and follow Master Manufacturing Records (MMRs):** No MMRs were prepared for Elderberry Concentrate Dietary Supplement products (21 CFR 111.205(a)). 2. **Incomplete Batch Production Records (BPRs):** The BPR for Elderberry Concentrate Dietary Supplement (batch no. 1149313) lacked crucial information such as equipment identity, cleaning dates, component unique identifiers, weights/measures, actual/theoretical yield, monitoring results, testing results, finished product specifications, and documentation of personnel initials for various production steps, packaging, labeling, and quality control reviews (21 CFR 111.255(b), 111.260). 3. **Failure to collect and hold reserve samples:** The firm admitted not collecting reserve samples due to a two-year shelf life (21 CFR 111.83(a)). 4.