# FDA 483 - Spectrum Pharmaceuticals, Inc. - February 12, 2020

Source: https://www.globalkeysolutions.net/records/483/spectrum-pharmaceuticals-inc/3ae6deb6-ea4b-41f4-9fe6-c56a8fb1ece1

> FDA 483 for Spectrum Pharmaceuticals, Inc. on February 12, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spectrum Pharmaceuticals, Inc.
- Inspection Date: 2020-02-12
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Spectrum Pharmaceuticals Inc. in Irvine, CA, revealed that the firm failed to promptly bring noncompliant investigators into compliance during clinical studies SPI-GCF-301 and SPI-GCF-302. This included numerous protocol deviations, missed study procedures, and significant delays in completing electronic case report forms (eCRFs). This issue was a repeat observation from a previous inspection.

## Related Documents

- [483 - 2016-05-27](https://www.globalkeysolutions.net/records/483/spectrum-pharmaceuticals-inc/f1b02020-a69a-4ae1-a502-d4bd9cca549b)
- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/spectrum-pharmaceuticals-inc/3e23b8cc-3896-4261-8692-d70bdc16a4a4)

## Related Officers

- [Lavender M Huskey](https://www.globalkeysolutions.net/people/lavender-m-huskey/9ad3f3d7-4f25-492a-b10a-ede8289e4797)
- [investigator](https://www.globalkeysolutions.net/people/angela-shepas/743113c1-799b-44e9-9422-8049c476bfd2)

Company: https://www.globalkeysolutions.net/companies/spectrum-pharmaceuticals-inc/d2be8240-3764-497f-8d0d-fbedb45f3053

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