FDA 483 - OLIVE BRANCH NATURAL BODY CARE LLC - April 02, 2019

An FDA inspection of OLIVE BRANCH NATURAL BODY CARE LLC, an OTC drug manufacturer in Seattle, revealed severe deficiencies in its quality system. The firm lacks a defined quality control unit, complete batch production records, and adequate testing for drug product release. Furthermore, there are no written procedures for equipment cleaning, stability testing, raw material handling, or complaint management, indicating a pervasive lack of GMP compliance.