# FDA 483 - Spectrum Pharmaceuticals, Inc. - May 27, 2016

Source: https://www.keypedia.com/records/483/spectrum-pharmaceuticals-inc/f1b02020-a69a-4ae1-a502-d4bd9cca549b

> FDA 483 for Spectrum Pharmaceuticals, Inc. on May 27, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spectrum Pharmaceuticals, Inc.
- Inspection Date: 2016-05-27
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Spectrum Pharmaceuticals Inc. in Irvine, CA, was cited for significant deficiencies in its clinical trial monitoring processes. The inspection revealed failures to properly report protocol deviations in submitted NDA data listings and delays in drafting and submitting monitoring reports. Additionally, the firm did not promptly address and document non-compliance by investigators, lacking evidence of corrective actions or a developed plan.

## Related Documents

- [483 - 2020-02-12](https://www.keypedia.com/records/483/spectrum-pharmaceuticals-inc/3ae6deb6-ea4b-41f4-9fe6-c56a8fb1ece1)
- [CRL - Unknown Date](https://www.keypedia.com/records/crl/spectrum-pharmaceuticals-inc/3e23b8cc-3896-4261-8692-d70bdc16a4a4)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/diane-c-van-leeuwen/98af0d70-2db1-4132-8193-fcccf8841960)

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

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