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# FDA Releases 2 Zhejiang Huahai Inspection ‘483s
- URL: https://www.fdaweb.com/fda-releases-2-zhejiang-huahai-inspection-483s/
- Published: 2018-08-16T12:00:00.000Z
- Updated: 2026-09-15T00:26:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142128

FDA has released the FDA-483s issued following a 11/14-11/18/16 and 5/15-5/19/17 inspection at Zhejiang Huahai Pharmaceutical Co., Zhejiang, China, an active pharmaceutical ingredient manufacturer that is the reported manufacturer of the active ingredient in recalled valsartan-containing products. Observations in the [2016 form](http://www.fda.gov/downloads/GuidanceComplianceRegulatoryInformation/CDERFOIAReadingRoom/UCM616394.pdf?ref=fdaweb.com) were: 

- failing to follow written procedures designed to prevent contamination of drug products purporting to be sterile;
- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
- processing areas are deficient regarding the system for cleaning and disinfecting the equipment; and
- Data is not recorded contemporaneously.

Observations on the [2017 form](http://www.fda.gov/downloads/GuidanceComplianceRegulatoryInformation/CDERFOIAReadingRoom/UCM616397.pdf?ref=fdaweb.com) were: 

- failing to implement appropriate controls over quality control instruments to ensure the integrity of analytical testing and failing to investigate analytical testing anomalies;
- facilities and equipment are not maintained to ensure quality attributes of drug product; and
- invalidation of out-of-specification results lacks adequate scientific justification.