# FDA 483 - Spectrum Laboratory Products, Inc. - March 20, 2026

Source: https://www.keypedia.com/records/483/spectrum-laboratory-products-inc/83ffee83-4936-45ee-999e-bb0a941a7af7

> FDA 483 for Spectrum Laboratory Products, Inc. on March 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spectrum Laboratory Products, Inc.
- Inspection Date: 2026-03-20
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Spectrum Laboratory Products, Inc. in Gardena, CA, an API Repacker and Relabeler, was cited for significant deficiencies during an FDA inspection. The observations primarily concern failures in quality unit documentation, inadequate facility and equipment cleanliness, and a lack of proper validation and monitoring of cleaning procedures. These issues indicate a systemic breakdown in maintaining a state of control over critical quality operations.

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- [483 - 2021-03-12](https://www.keypedia.com/records/483/spectrum-laboratory-products-inc/5ae7e897-4c79-43d3-b4af-e52346dc7fed)
- [EIR - 2016-08-25](https://www.keypedia.com/records/eir/spectrum-laboratory-products-inc/6afd7249-c138-45a6-ad3c-81f0ba03f771)
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- [WARNING_LETTER - 2018-11-16](https://www.keypedia.com/records/warning_letter/spectrum-laboratory-products-inc/e82f6232-6919-4024-b15a-c8dda0796972)

## Related Officers

- [Matthew R. Clabeaux](https://www.keypedia.com/people/matthew-r-clabeaux/9acc9b47-4063-4582-ac9a-983a07079495)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b