FDA 483 - Zhejiang Huahai Pharmaceutical - November 20, 2024

On November 12-20, 2024, an FDA inspection of Zhejiang Huahai Pharmaceutical Co., Ltd., an API Manufacturer in Linhai, Taizhou Zhejiang, China, revealed eight observations.

**Observation 1:** Laboratory records lacked complete test data for equipment cleaning samples (swab and rinse). Specifically, there was no documentation of raw test data for cleaning test solution preparation for UV Spectroscopy and TOC methods, impacting reliability of results and OOS investigations. This issue affects all APIs and intermediates, including those for the U.S. market, and indicates deviations from SOP QC-021-19 and SMP-035.05 regarding record-keeping and data integrity. Additionally, no documented test procedures existed for diluent, test solution, and reference standard preparation for U.S. market APIs.

**Observation 2:** Deviations from analytical test procedures were not investigated. The Quality Control Unit did not prepare and test reference standard solutions for equipment cleaning samples to ensure system suitability. QC Engineers used an "E value" calculation instead of linear equation calculation as per test procedures QS-C054 and QS-C006, and bypassed linearity plot establishment, rendering cleaning sample test results unreliable for all U.S. market APIs and intermediates.

**Observation 3:** Laboratory investigations for Out-of-Specification (OOS) cleaning sample failures were inadequate. Investigations lacked scientific justification and documented evidence for probable root causes.