# FDA 483 - Zyno Electric & Machinery Ltd, Shanghai - August 16, 2018

Source: https://www.keypedia.com/records/483/zyno-electric-machinery-ltd-shanghai/554a80ed-e158-412f-b417-9d7f1c43a017

> FDA 483 for Zyno Electric & Machinery Ltd, Shanghai on August 16, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zyno Electric & Machinery Ltd, Shanghai
- Inspection Date: 2018-08-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Zyno Electric & Machinery Ltd in Shanghai, China, a manufacturer of infusion pumps, identified one significant observation. The firm failed to adequately establish procedures for controlling environmental conditions, specifically regarding the prevention and control of Electrostatic Discharge (ESD). This included issues such as missing ESD ground wire systems on workbenches and storage, and improper use of wrist straps by personnel.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/zyno-electric-machinery-ltd-shanghai/8516cc6e-5a6d-4962-b8c4-b523aab8388b

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