# FDA 483 - Enter Medical Corporation - February 28, 2019

Source: https://www.keypedia.com/records/483/enter-medical-corporation/44c0f52f-3536-4f01-9785-ec513383c8fa

> FDA 483 for Enter Medical Corporation on February 28, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Enter Medical Corporation
- Inspection Date: 2019-02-28
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: During an inspection of Enter Medical Corporation, a medical device manufacturer in Hsin Kang Township, Chiayi County, Taiwan, the FDA observed a lack of documentation for out-of-calibration equipment and subsequent remedial actions. Specifically, an Air Leakage Test equipment was found to be overdue for calibration. This indicates a moderate severity issue related to quality system controls for equipment maintenance.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/enter-medical-corporation/446a4ae6-6bb7-477f-ad32-b68e43fd8720

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