# FDA 483 - Xiantao Zhongtai Protective Products Co.,Ltd - August 01, 2019

Source: https://www.keypedia.com/records/483/xiantao-zhongtai-protective-products-coltd/dbe1d749-c812-4510-926d-9f3b7944463d

> FDA 483 for Xiantao Zhongtai Protective Products Co.,Ltd on August 01, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xiantao Zhongtai Protective Products Co.,Ltd
- Inspection Date: 2019-08-01
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Xiantao Zhongtai Protective Products Co.,Ltd in Xiantao City, China, revealed four observations related to inadequate procedures. The firm was cited for deficiencies in preventing contamination, equipment maintenance, storage area control, and quality audit practices. These issues indicate a need for improved procedural controls within the manufacturing and quality systems.

## Related Officers

- [Dedicated Device Cadre](https://www.keypedia.com/people/dedicated-device-cadre/693932db-dd86-453f-9b51-a63444b07281)
- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/xiantao-zhongtai-protective-products-coltd/def44d54-4baf-43b8-8910-36b5d5dcf62c

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