# FDA 483 - Cosway Company, Inc. - April 08, 2011

Source: https://www.globalkeysolutions.net/records/483/cosway-company-inc/a97dc147-e70b-4829-a9fb-3d049775e069

> FDA 483 for Cosway Company, Inc. on April 08, 2011. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Cosway Company, Inc.
- Inspection Date: 2011-04-08
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Cosway Company Inc. in Carson, CA, revealed significant deficiencies across its quality, laboratory, and production systems. Key issues included inadequate change control, deficient complaint record procedures, and failures in stability testing and cleaning validation. These observations indicate a lack of robust quality oversight and control in the manufacturing of pharmaceutical and cosmetic products.

## Related Documents

- [483 - 2011-11-10](https://www.globalkeysolutions.net/records/483/cosway-company-inc/fa6bbe76-2ae5-4c13-9d5b-afd4b78ae45b)
- [483 - 2023-02-24](https://www.globalkeysolutions.net/records/483/cosway-company-inc/9214be1a-b377-4d30-8c4a-b469cc435edb)
- [483 - 2013-07-11](https://www.globalkeysolutions.net/records/483/cosway-company-inc/00f39318-d058-4172-95b0-f341cdb75719)
- [483 - 2013-07-11](https://www.globalkeysolutions.net/records/483/cosway-company-inc/96ba4a63-dbc9-4192-8b5f-ef7f926147e4)
- [483 - 2023-10-27](https://www.globalkeysolutions.net/records/483/cosway-company-inc/8c297bc9-3755-4b21-a093-5ae560a0ac53)

## Related Officers

- [Zachary A. Bogorad](https://www.globalkeysolutions.net/people/zachary-a-bogorad/ae582dcd-f893-44a5-98bd-0b55f401577b)

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