# FDA 483 - Shanwei Honghui Daily Appliance Co., Ltd. - August 03, 2017

Source: https://www.globalkeysolutions.net/records/483/shanwei-honghui-daily-appliance-co-ltd/2dcf3ef4-3168-44e1-8824-8d332cf9ad57

> FDA 483 for Shanwei Honghui Daily Appliance Co., Ltd. on August 03, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shanwei Honghui Daily Appliance Co., Ltd.
- Inspection Date: 2017-08-03
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Shanwei Honghui Daily Appliance Co., Ltd., an OTC drug manufacturer in Shanwei City, China, revealed significant deficiencies across its quality control, production, and laboratory systems. The firm was cited for lacking adequate quality unit oversight, failing to validate processes and equipment, insufficient personnel training, and inadequate microbial testing and equipment cleaning. These issues indicate a systemic failure to adhere to Good Manufacturing Practices, posing risks to product quality and safety.

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Company: https://www.globalkeysolutions.net/companies/shanwei-honghui-daily-appliance-co-ltd/976a9803-a7ff-4768-ab1b-6946f0c65d8d

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd