# FDA 483 - Kingkey MBC Life Technology Group Co., Ltd. - March 04, 2019

Source: https://www.globalkeysolutions.net/records/483/kingkey-mbc-life-technology-group-co-ltd/674d7beb-2169-42c2-a21f-2b5aca6dae55

> FDA 483 for Kingkey MBC Life Technology Group Co., Ltd. on March 04, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kingkey MBC Life Technology Group Co., Ltd.
- Inspection Date: 2019-03-04
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Kingkey MBC Life Technology Group Co., Ltd. in Chenghai, Shantou, Guangdong, China, revealed significant deficiencies in their manufacturing processes. Observations included inadequate laboratory controls for sampling plans, a lack of proper two-person verification for component additions and weight checks, and the absence of routine calibration for critical electronic equipment. These findings indicate a failure to adhere to established quality control and good manufacturing practices.

## Related Officers

- [Retired](https://www.globalkeysolutions.net/people/ariel-cruz-figueroa/c6ade050-dbe1-4aa3-b88f-980db51b88b0)

Company: https://www.globalkeysolutions.net/companies/kingkey-mbc-life-technology-group-co-ltd/40cceb6c-350d-44d3-aeb4-9652b4e5c303

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1