# FDA 483 - Holymed Products Co., Ltd. - June 19, 2019

Source: https://www.keypedia.com/records/483/holymed-products-co-ltd/20a8ea68-17ad-4e4e-959a-956a5e5c5ba6

> FDA 483 for Holymed Products Co., Ltd. on June 19, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Holymed Products Co., Ltd.
- Inspection Date: 2019-06-19
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Holymed Products Co. Ltd., a medical device contract manufacturer in Changzhou, China, was cited with two observations during an FDA inspection. The firm failed to adequately control environmental conditions and maintain related records for device manufacturing. Additionally, the company did not maintain complete Device History Records for certain products.

## Related Officers

- [Shaquenta Perkins](https://www.keypedia.com/people/shaquenta-perkins/00369bbd-5784-42c2-847e-202c8b1b87a2)

Company: https://www.keypedia.com/companies/holymed-products-co-ltd/b73b5c31-5d73-48da-95f7-0777092db0d2

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