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

Source: https://www.keypedia.com/records/483/cosway-company-inc/8c297bc9-3755-4b21-a093-5ae560a0ac53

> 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: Los Angeles District Office
- Summary: Cosway Company, Inc., a contract manufacturer, underwent an FDA inspection from October 25 to October 27, 2023. The inspection revealed two primary observations regarding the firm's operational controls and quality management for drug products. The first observation highlighted inadequate controls over computer systems. Specifically, an unvalidated Excel spreadsheet was utilized since 2019 for storing stability data and generating Formal Compatibility Reports for over-the-counter (OTC) drug products. This system lacked an audit trail and sufficient security to prevent unauthorized data modifications. A procedural flaw was also noted where reports could be approved before being prepared. The second observation detailed a failure to thoroughly investigate unexplained discrepancies. Numerous out-of-specification temperature and humidity readings in stability chambers, used for OTC drug product studies, were recorded between February and October 2023 without proper investigation, even as stability samples for distributed products were stored there. These observations indicate a need for the company to enhance its data integrity and quality assurance processes, aligning with good manufacturing practices to ensure the reliability and safety of its drug products.

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- [483_RESPONSE - 2023-10-27](https://www.keypedia.com/records/483_response/cosway-company-inc/8ef278b0-ea71-40b9-8542-756549a2f557)

## Related Officers

- [recipient](https://www.keypedia.com/people/gregory-v-chambers/3f8b9da9-2e18-4fc0-9937-6451827597b4)
- [Sara H. Gabel](https://www.keypedia.com/people/sara-h-gabel/cd0cd510-ef95-4322-a766-503c994c1f64)
- [Consumer Safety Officer](https://www.keypedia.com/people/kenneth-o-gee/d61312c0-1422-4487-a5d6-ec6e76d242ee)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b