# FDA 483 - Coretex Products Inc. - April 28, 2021

Source: https://www.globalkeysolutions.net/records/483/coretex-products-inc/ebdfd28a-048f-4024-8302-8479bda02ea9

> FDA 483 for Coretex Products Inc. on April 28, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Coretex Products Inc.
- Inspection Date: 2021-04-28
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Coretex Products Inc. in Bakersfield, CA, a packer/repacker of drug products, revealed significant deficiencies in production, labeling, and equipment cleaning controls. The firm failed to validate critical processes and cleaning procedures, leading to issues like underweight products and incorrect label usage. These observations indicate a lack of adequate controls to ensure drug product quality, identity, and purity.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/lisa-shin/13c87687-fe3d-41a5-8973-42be901a5b0c)

Company: https://www.globalkeysolutions.net/companies/coretex-products-inc/87a5052d-fa58-4a3b-a539-e370f53b05bf

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6