# FDA 483 - Medsource Pharmaceuticals - December 05, 2019

Source: https://www.globalkeysolutions.net/records/483/medsource-pharmaceuticals/933f4e30-af21-40fd-8d8b-26865bf49fbb

> FDA 483 for Medsource Pharmaceuticals on December 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medsource Pharmaceuticals
- Inspection Date: 2019-12-05
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Medsource Pharmaceuticals, a drug repacker and relabeller in Rancho Santa Margarita, CA, received an FDA Form 483 citing significant deficiencies across its quality system, production controls, and equipment management. Observations included a lack of annual product reviews, a deficient change control program, absence of expiration dating procedures for repackaged drugs, and inadequate cleaning validation and equipment qualification. These issues indicate a broad failure to ensure product quality and compliance with good manufacturing practices.

## Related Officers

- [Alan L. Truong](https://www.globalkeysolutions.net/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)
- [Professor](https://www.globalkeysolutions.net/people/liming-zhang/6c93b721-8725-4d87-8a42-254f3de5e49d)

Company: https://www.globalkeysolutions.net/companies/medsource-pharmaceuticals/35015922-a2dd-4cc5-96b2-258f9c7b5260

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