# FDA 483 - ModernaTX, Inc. - September 21, 2023

Source: https://www.keypedia.com/records/483/modernatx-inc/551e32ae-9508-4418-83f1-039c4a3499e5

> FDA 483 for ModernaTX, Inc. on September 21, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ModernaTX, Inc.
- Inspection Date: 2023-09-21
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: ModernaTX, Inc. in Norwood, MA, a licensed biological drug substance manufacturer, was cited for five observations during an FDA inspection. The firm failed to ensure proper cleaning of manufacturing equipment and validate cleaning processes, leading to potential contamination risks. Additionally, deficiencies were noted in inventory management with expired materials, adherence to written procedures for alarm responses and change control, and maintaining adequate cleanroom environmental controls.

## Related Documents

- [483 - 2023-09-21](https://www.keypedia.com/records/483/modernatx-inc/1583f95f-f001-42f8-b300-875d5e40759c)

## Related Officers

- [Product Specialist ](https://www.keypedia.com/people/swati-verma/4ef6b918-6193-4ef8-96e6-270a7f837deb)
- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)
- [Urinee Ranjan](https://www.keypedia.com/people/urinee-ranjan/ae08efcf-b575-4fde-b8e2-e1ade0b18a1e)
- [Regulatory Counsel ](https://www.keypedia.com/people/ben-firschein/fe0ccdcd-4a91-401a-b01a-d15db8a8a04d)

Company: https://www.keypedia.com/companies/modernatx-inc/8d0092a3-f330-4ddf-ae1f-f4dd9c0aba6e

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