FDA WARNING_LETTER - Elemental Herbs Inc. d/b/a ALL good - February 03, 2023

On October 20, 2023, the FDA issued a Warning Letter to Elemental Herbs Inc., doing business as “ALL good,” following an inspection from January 23 to February 3, 2023. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Inadequate Quality Unit (21 CFR 211.22(a) and 211.22(d)):** The Quality Unit failed to provide adequate oversight in areas such as CMO qualification, drug product specifications, complaint sharing with CMOs, change management, and product return investigations. The firm's response, proposing a consultant and SOP development without interim actions or timelines, was deemed inadequate. 2. **Inadequate Stability Program (21 CFR 211.166(a)):** The firm failed to establish an adequate stability program to determine expiration dates for OTC drug products. Their response, committing to a CMO stability program review without a proposed initiation date or updated protocols, was insufficient.

Additionally, "ALL good Goop Skin Recovery Balm" was identified as an unapproved new drug and misbranded. Its labeling claims, such as "Goop is great on cuts, scrapes, cracked heels, burns, bites and almost anything that needs