# FDA 483 - Spectrum Laboratory Products, Inc. - November 13, 2018

Source: https://www.keypedia.com/records/483/spectrum-laboratory-products-inc/5e785bcb-b554-48aa-9e7d-1cdecc704e6a

> FDA 483 for Spectrum Laboratory Products, Inc. on November 13, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spectrum Laboratory Products, Inc.
- Inspection Date: 2018-11-13
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Spectrum Laboratory Products Inc. in Gardena, CA, a repacker/relabeler, was cited with three observations during an FDA inspection. The firm failed to ensure Certificates of Analysis for repackaged APIs included original manufacturer details and lacked traceability in relabeling operations. Additionally, the quality management system was found inadequate, with failures in conducting investigations for product issues and determining root causes for complaints.

## Related Documents

- [EIR - 2016-08-25](https://www.keypedia.com/records/eir/spectrum-laboratory-products-inc/6afd7249-c138-45a6-ad3c-81f0ba03f771)
- [EIR - 2018-11-16](https://www.keypedia.com/records/eir/spectrum-laboratory-products-inc/1f043aa3-5c33-486b-ada2-38deee86e762)
- [WARNING_LETTER - 2018-11-16](https://www.keypedia.com/records/warning_letter/spectrum-laboratory-products-inc/e82f6232-6919-4024-b15a-c8dda0796972)
- [WARNING_LETTER - 2019-03-12](https://www.keypedia.com/records/warning_letter/spectrum-laboratory-products-inc/affa8862-8b7f-4c0e-addb-eef2d429c84b)
- [483 - 2021-03-12](https://www.keypedia.com/records/483/spectrum-laboratory-products-inc/5ae7e897-4c79-43d3-b4af-e52346dc7fed)

## Related Officers

- [Kristin M. Abaonza](https://www.keypedia.com/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)

Company: https://www.keypedia.com/companies/spectrum-laboratory-products-inc/c520c090-6922-4246-a7a9-34f771182cb6

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