> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 7 Observations in Zhejiang Huahai FDA-483
- URL: https://www.fdaweb.com/7-observations-in-zhejiang-huahai-fda-483/
- Published: 2025-02-27T12:00:00.000Z
- Updated: 2026-09-14T14:54:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158738

FDA has released the form FDA-483 issued following an 11/12-11/20/2024 inspection at the Zhejiang Huahai Pharmaceutical Co. active pharmaceutical ingredient (API) manufacturing facility in Linhai, Taizhou Zhejiang, China. The seven inspection observations were:

- failure of laboratory records to include complete test data derived from all tests;
- failure to investigate deviations from analytical test procedures;
- failure to adequately conduct laboratory investigations to determine the root cause;
- failure to always investigate deviation investigations relating to facility, equipment, and production;
- lack of quality unit oversight to ensure the integrity of test data and document management;
- master batch production record lacks established time limits and detailed production instructions to ensure the quality of intermediates and APIs are met for individual processing steps and/or total process;
- failure to maintain equipment used in the manufacture of intermediates and APIs in a good state of repair to prevent contamination that would alter the safety, identity, strength, quality, and purity of the drug product; and
- the procedure for collecting cleaning samples from the manufacturing equipment is deficient.