# FDA 483 - ATC Technologies, Inc. - October 07, 2019

Source: https://www.keypedia.com/records/483/atc-technologies-inc/e4400c4d-2054-4cf3-96d0-725d0af820a7

> FDA 483 for ATC Technologies, Inc. on October 07, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ATC Technologies, Inc.
- Inspection Date: 2019-10-07
- Product Type: other
- Office Name: Division of Northeast Imports 
- Summary: ATC Technologies, Inc., a manufacturer in Wilmington, MA, was cited for significant quality system deficiencies during an FDA inspection. The inspection revealed repeat observations concerning inadequate corrective and preventive action procedures and supplier/contractor management. Additional issues included undocumented equipment calibrations and poor environmental control in clean rooms, evidenced by particulate accumulation.

## Related Officers

- [Investigator](https://www.keypedia.com/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)

Company: https://www.keypedia.com/companies/atc-technologies-inc/5493093c-cf7e-43f8-acb9-b7472ec99ccb

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