FDA WARNING_LETTER - Eden’s Answers, Inc. - November 09, 2022

The FDA inspected a manufacturing facility in Holmesville, OH, from August 22 to November 9, 2022, identifying serious violations of the Federal Food, Drug, and Cosmetic Act and dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Products including Dental Health, Honey Herbal Syrup, and Lil’ Ones Sleepy Time were deemed adulterated.

Key violations include: 1. **Failure to establish specifications:** No identity specifications for components (e.g., catnip, chamomile) or for the identity, purity, strength, and composition of finished products (e.g., Lil’ Ones Sleepy Time, Dental Health, Honey Herbal Syrup). General descriptions like "Liquid" or "Amber" were insufficient, and methods like "HPTLC" or "FTIR" were not specific enough to verify identity, purity, strength, and composition. 2. **Incomplete batch production records:** Batch records for Honey Herbal Syrup, Lil Ones Sleepy Time, and Natural Health Dental Health lacked documentation of equipment maintenance, cleaning, and sanitizing dates/times, or cross-references to such records. 3. **Inadequate master manufacturing records:** The master production record for Honey Herbal Syrup lacked specifications and written instructions for critical control points, such as temperature monitoring during a manufacturing step. 4. **Failure of quality control:** Quality control personnel did not conduct material reviews or make disposition decisions