# FDA 483 - Applied Tissue Technologies LLC - December 11, 2019

Source: https://www.keypedia.com/records/483/applied-tissue-technologies-llc/51bcdaaa-6f93-478e-8751-5a2b33e2b8e4

> FDA 483 for Applied Tissue Technologies LLC on December 11, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Applied Tissue Technologies LLC
- Inspection Date: 2019-12-11
- Product Type: other
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Applied Tissue Technologies LLC in Hingham, MA, conducted from December 10-11, 2019, identified one observation. The firm's corrective and preventive action (CAPA) procedures were found to be inadequately established. Specifically, the procedures lacked provisions for employing statistical methodology to detect recurring quality problems, and no CAPA was initiated despite multiple complaints regarding the same issue with a product's mincer blades.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/applied-tissue-technologies-llc/de147fb2-7652-470a-993f-7803195cce63

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