FDA WARNING_LETTER - Washington Homeopathic Products, Inc. - July 02, 2019

The FDA inspected Washington Homeopathic Products, Inc. (FEI 3006489197) from June 18 to July 2, 2019, identifying significant CGMP violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Violations include: 1. **Inadequate Quality Control Unit (QCU):** The firm failed to establish an adequate QCU with authority to approve/reject materials and products, and lacked written QCU procedures (21 CFR 211.22(a) and (d)). The QCU lacked oversight for homeopathic products and components, including those from a supplier, (b)(4), placed on import alert for egregious CGMP violations. The firm continued distributing products from (b)(4) despite knowing of the violations. Corrective actions were deemed inadequate, failing to demonstrate improved oversight or supplier qualification remediation from a prior 2018 inspection. 2. **Failure to Identity Test Components:** The firm failed to conduct at least one identity test for each component lot before use in manufacturing (21 CFR 211.84(d)(1)). The response was inadequate, lacking test results for components released without identity testing and clarity on risk assessment. 3. **Unvalidated Test Methods:** The firm failed to establish and document accuracy, sensitivity, specificity,