# FDA 483 - Spectrum Laboratory Products, Inc. - March 12, 2019

Source: https://www.keypedia.com/records/483/spectrum-laboratory-products-inc/51ba0d4f-2eac-4847-b63d-70482fd924fe

> FDA 483 for Spectrum Laboratory Products, Inc. on March 12, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spectrum Laboratory Products, Inc.
- Inspection Date: 2019-03-12
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Spectrum Laboratory Products Inc. in New Brunswick, NJ, was inspected as an active pharmaceutical ingredients repackager and relabeler. The inspection revealed failures to ensure requirements for Certificates of Analysis and relabeling operations. These issues indicate a lack of traceability to original manufacturers for repackaged and relabeled APIs.

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## Related Officers

- [Compliance Officer at FDA](https://www.keypedia.com/people/emmanuel-j-ramos/ba0666bd-2752-453e-9fd3-5e43b1cff3ad)

Company: https://www.keypedia.com/companies/spectrum-laboratory-products-inc/fe7de08b-b36d-479a-8644-33b183972639

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248