# FDA 483 - Beijing HKKY Medical Tech. Co., Ltd. - July 12, 2019

Source: https://www.keypedia.com/records/483/beijing-hkky-medical-tech-co-ltd/fd9da115-025a-41a1-bd0a-1aaf30be8afc

> FDA 483 for Beijing HKKY Medical Tech. Co., Ltd. on July 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beijing HKKY Medical Tech. Co., Ltd.
- Inspection Date: 2019-07-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Beijing HKKY Medical Tech. Co., Ltd. in Beijing, a manufacturer of OTC Finished Products, revealed two significant quality control deficiencies. The firm failed to adequately test drug product batches for objectionable microorganisms and lacked proper calibration records for a non-viable particle counter. These issues indicate a lack of robust quality assurance for products shipped to the USA.

## Related Officers

- [Senior Lead Reviewer and Intercenter Consult Team Leader](https://www.keypedia.com/people/nayan-j-patel/0436f014-4b1b-4e54-8df0-576d51a354b2)

Company: https://www.keypedia.com/companies/beijing-hkky-medical-tech-co-ltd/2412dc3e-d182-40ff-baa4-8b906e2e7663

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