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# FDA Releases 2 FDA-483s for Zhejiang Hisun
- URL: https://www.fdaweb.com/fda-releases-2-fda-483s-for-zhejiang-hisun/
- Published: 2022-03-29T12:00:00.000Z
- Updated: 2026-09-14T17:38:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151478

FDA has just released the FDA-483s issued following 1/16-1/19/2017 and 8/7-8/11/2017 inspections at Zhejiang Hisun Pharmaceutical Co., a Taizhou City, Zhejiang, China, active pharmaceutical ingredient manufacturer. The form for the January inspection had these observations: 

- failing to follow quality control laboratory control procedures; and
- failing to justify labeled storage conditions by stability studies.

The observations from the August inspection were: 

- laboratory records do not always include relevant metadata to ensure that established procedures are followed;
- written procedures are deficient regarding the cleaning and maintenance of equipment;
- storage conditions for samples retained for testing are not monitored appropriately;
- records are not completed contemporaneously;
- laboratory records do not include complete data derived from microbial limit testing to ensure established procedures are followed;
- changes to manufacturing processes are not fully documented;
- process validating studies do not contain a history of all relevant data; and
- the final API storage areas are not maintained in a good state of repair.