# FDA 483 - Tepha Incorporated - May 13, 2022

Source: https://www.keypedia.com/records/483/tepha-incorporated/0ce8abb5-6b08-47e1-91ff-739a9d537656

> FDA 483 for Tepha Incorporated on May 13, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tepha Incorporated
- Inspection Date: 2022-05-13
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Tepha Incorporated in Lexington, MA, from May 11-13, 2022, identified one significant observation. The firm's procedures for corrective and preventive action were found to be inadequately established. Specifically, the effectiveness check for CAPA #1121 was deemed insufficient.

## Related Officers

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

Company: https://www.keypedia.com/companies/tepha-incorporated/ae8225e9-08cd-4027-8366-c5add9c3cf0b

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