# FDA 483 - Ming Fai Industrial (Shenzhen) Co LTD - August 11, 2017

Source: https://www.globalkeysolutions.net/records/483/ming-fai-industrial-shenzhen-co-ltd/d0e6a9b8-9a5a-4212-b61d-156a2b68e9c5

> FDA 483 for Ming Fai Industrial (Shenzhen) Co LTD on August 11, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ming Fai Industrial (Shenzhen) Co LTD
- Inspection Date: 2017-08-11
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Mingfai Industrial (Shenzhen) Co., Ltd., an OTC drug manufacturer, revealed significant deficiencies in their production, quality control, laboratory, and equipment systems. The firm lacked adequate written procedures, process validation, proper testing, and robust quality unit oversight. These issues indicate a failure to ensure drug product identity, strength, quality, and purity.

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