# FDA 483 - Netech Corp. - April 14, 2023

Source: https://www.globalkeysolutions.net/records/483/netech-corp/9fa8eb26-afda-44eb-8875-7f3871f7b615

> FDA 483 for Netech Corp. on April 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Netech Corp.
- Inspection Date: 2023-04-14
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Netech Corp., a medical device manufacturer in Farmingdale, NY, was cited for three observations during an FDA inspection. The firm failed to adequately document equipment calibrations and maintain complete device history records. Additionally, Netech Corp. lacked proper electronic Medical Device Reporting (eMDR) procedures and an Electronic Submissions Gateway (ESG) account.

## Related Documents

- [483 - 2019-10-08](https://www.globalkeysolutions.net/records/483/netech-corp/17ebf68e-ea21-4031-9834-2e0048519c77)

## Related Officers

- [Raihan A. Chowdhury](https://www.globalkeysolutions.net/people/raihan-a-chowdhury/739813d5-2f9b-4048-91c7-911fd595f8d3)
- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.globalkeysolutions.net/companies/netech-corp/ec4307e9-5436-47cd-8ef8-ce55d364ed8d

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961