# Nitto Denko Avecia Inc. – FDA 483, Feb 8, 2023

Source: https://www.keypedia.com/records/483/nitto-denko-avecia-inc/482e7a9e-2f50-46c6-a4c4-1690dbf9267f

> FDA 483 for Nitto Denko Avecia Inc. on February 08, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nitto Denko Avecia Inc.
- Inspection Date: 2023-02-08
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Nitto Denko Avecia Inc., an API manufacturer in Milford, MA, revealed significant deficiencies across its quality systems. Observations included inadequate deviation investigations, poor retention and security of batch records, failure to adhere to stability testing procedures, and untimely review of quality reports. Additionally, the facility exhibited inadequate cleaning of manufacturing areas and equipment, indicating a broad lack of GMP compliance.

## Related Documents

- [EIR - 2018-05-10](https://www.keypedia.com/records/eir/nitto-denko-avecia-inc/509888a7-812d-4833-a0cf-05fdb8822327) — date: May 10, 2018

## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

Company: https://www.keypedia.com/companies/nitto-denko-avecia-inc/985d1d1a-8b33-4713-a5b8-d6f0e1b83528

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