# FDA 483 - Cosway Company, Inc. - February 24, 2023

Source: https://www.keypedia.com/records/483/cosway-company-inc/a9c774a6-dd99-487d-82a6-4e6162ba02a9

> FDA 483 for Cosway Company, Inc. on February 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosway Company, Inc.
- Inspection Date: 2023-02-24
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Cosway Company, Inc. in Carson, CA, a contract manufacturer, was inspected by the FDA from February 16-24, 2023. The inspection revealed two significant issues: a lack of qualified laboratory equipment for testing OTC drug products and a failure to investigate temperature excursions in warehouses where drug products and raw materials were stored. These conditions indicate potential deficiencies in quality control and product integrity.

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## Related Officers

- [investigator](https://www.keypedia.com/people/heidy-c-perales/fdf71c74-8cb7-41b5-9070-6b8eb11cb404)

Company: https://www.keypedia.com/companies/cosway-company-inc/ae940b3a-15a4-4fda-bbd6-4b171ff3fee0

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