# FDA 483 - Fomed Industries Inc. - July 11, 2019

Source: https://www.keypedia.com/records/483/fomed-industries-inc/16a7c8af-b71c-4c06-92af-b75eb65573e0

> FDA 483 for Fomed Industries Inc. on July 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fomed Industries Inc.
- Inspection Date: 2019-07-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Fomed Industries Inc., a medical device manufacturer in Qian Jiang City, Hubei, China, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design validation, control of nonconforming products, management review, and labeling activities. These issues indicate a broad lack of adherence to quality system requirements for medical device manufacturing.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.keypedia.com/companies/fomed-industries-inc/99fb0547-b508-490e-8321-0c441ce5378f

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