# FDA 483 - Cosway Company, Inc. - October 27, 2023

Source: https://www.globalkeysolutions.net/records/483/cosway-company-inc/7e6674ce-c701-4bb4-820b-72f144a37352

> FDA 483 for Cosway Company, Inc. on October 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosway Company, Inc.
- Inspection Date: 2023-10-27
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Cosway Company, Inc. in Carson, CA, a contract manufacturer of OTC drug products, was cited for significant deficiencies during an FDA inspection. Observations included a lack of appropriate controls over computer systems, specifically an unvalidated Excel spreadsheet used for stability data without an audit trail or proper security. Additionally, the firm failed to thoroughly investigate out-of-specification temperature and humidity readings for stability chambers used in OTC drug product stability studies.

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- [483 - 2023-10-27](https://www.globalkeysolutions.net/records/483/cosway-company-inc/8c297bc9-3755-4b21-a093-5ae560a0ac53)

## Related Officers

- [Ken Gee](https://www.globalkeysolutions.net/people/ken-gee/7661428f-58e2-4cd5-8273-096596f69572)
- [Sara H. Gabel](https://www.globalkeysolutions.net/people/sara-h-gabel/cd0cd510-ef95-4322-a766-503c994c1f64)

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

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