# FDA 483 - Hightech American Industrial Laboratories, Inc. - January 25, 2022

Source: https://www.keypedia.com/records/483/hightech-american-industrial-laboratories-inc/44d0910a-3cd4-4ada-a2b6-5bb10d04eedc

> FDA 483 for Hightech American Industrial Laboratories, Inc. on January 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hightech American Industrial Laboratories, Inc.
- Inspection Date: 2022-01-25
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Hightech American Industrial Laboratories, Inc. in Lexington, MA, revealed a significant compliance issue related to medical device labeling. The firm failed to establish a Unique Device Identifier (UDI) for its Eyebank Specular Microscope EB-3000XYZ, resulting in shipments without UDI since 2016. This indicates a lapse in ensuring proper identification and traceability for their medical devices.

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.keypedia.com/companies/hightech-american-industrial-laboratories-inc/bb3d64fe-43fa-4ab0-8ac9-969430c02328

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94