# FDA 483 - Cosway Company, Inc. - November 10, 2011

Source: https://www.keypedia.com/records/483/cosway-company-inc/cb9a69bb-f03d-435e-b6ee-afb8b122ca08

> FDA 483 for Cosway Company, Inc. on November 10, 2011. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosway Company, Inc.
- Inspection Date: 2011-11-10
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Cosway Company Inc, a manufacturer in Carson, CA, was cited for significant quality control deficiencies during an FDA inspection. The firm repeatedly released product batches despite out-of-specification results for specific gravity without conducting thorough investigations. This indicates a failure in their quality unit's oversight and investigation procedures, as well as a lack of collaboration with the product developer to resolve critical issues.

## Related Documents

- [EIR - 2011-11-10](https://www.keypedia.com/records/eir/cosway-company-inc/5bb1be08-c305-4419-859c-4d78667ea2ae)
- [EIR - 2023-02-24](https://www.keypedia.com/records/eir/cosway-company-inc/0f7a9b7c-c291-42cb-bfac-931db7600a1c)
- [EIR - 2013-06-18](https://www.keypedia.com/records/eir/cosway-company-inc/6d1c9afc-759d-40e8-9afe-c205bd221c5e)
- [EIR - 2024-09-06](https://www.keypedia.com/records/eir/cosway-company-inc/9116d2ec-7f55-4215-bf97-6a250869dcb7)
- [EIR - 2017-03-10](https://www.keypedia.com/records/eir/cosway-company-inc/ca2377b9-f01e-4ee5-b625-ddd24abc10e7)

## Related Officers

- [Investigator](https://www.keypedia.com/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

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