# FDA 483 - NuCare Pharmaceuticals Inc - January 10, 2020

Source: https://www.globalkeysolutions.net/records/483/nucare-pharmaceuticals-inc/86109b8c-2ba3-47fc-9824-cf956c6bf2dc

> FDA 483 for NuCare Pharmaceuticals Inc on January 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NuCare Pharmaceuticals Inc
- Inspection Date: 2020-01-10
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: NuCare Pharmaceuticals Inc in Orange, CA, was cited for issues related to drug product stability and expiration dating during repackaging operations. The firm failed to conduct stability studies for drug products repackaged without desiccants, yet assigned them the original expiration dates. This raises concerns about the quality and purity of the products over time.

## Related Documents

- [WARNING_LETTER - 2019-09-26](https://www.globalkeysolutions.net/records/warning_letter/nucare-pharmaceuticals-inc/4cf5529b-83bb-43b6-820d-9937ecf2f7e3)

## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.globalkeysolutions.net/companies/nucare-pharmaceuticals-inc/87b1bb13-0d96-4650-b811-1a3bd6eb2e17

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