# FDA 483 - Centrix, Inc. - March 02, 2022

Source: https://www.keypedia.com/records/483/centrix-inc/f3e24f2e-a641-45a7-a9f1-639a3bae6ad1

> FDA 483 for Centrix, Inc. on March 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Centrix, Inc.
- Inspection Date: 2022-03-02
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Centrix, Inc., an OTC drug manufacturer in Shelton, CT, was inspected and cited for significant deficiencies across its drug product manufacturing operations. Key issues include the absence of a formal stability testing program, inadequate control over incoming components and labeling, widespread failures to follow written procedures in production and maintenance, and a lack of documented cGMP training for employees. Many of these issues were previously observed or discussed in a 2017 FDA inspection, indicating persistent non-compliance.

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/samir-c-gala/904c34ee-013d-4663-a87a-9cbdbcf2b40e)

Company: https://www.keypedia.com/companies/centrix-inc/f67d1354-9497-4a39-9320-0be314e62568

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