# FDA 483 - Spectrum Laboratory Products, Inc. - March 24, 2023

Source: https://www.globalkeysolutions.net/records/483/spectrum-laboratory-products-inc/891f9b12-6243-47b8-b105-81a740f1f3f6

> FDA 483 for Spectrum Laboratory Products, Inc. on March 24, 2023. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spectrum Laboratory Products, Inc.
- Inspection Date: 2023-03-24
- Office Name: New Jersey District Office
- Summary: This FDA Form 483 documents observations from an inspection, indicating significant deficiencies in the facility's operations and quality systems.

**Facility and Operations:** The facility conducts repackaging operations, which are not performed under appropriate environmental conditions, leading to potential contamination and cross-contamination. The warehouse lacks defined areas or control systems for activities.

**Violations and Observations:**
*   **Environmental Control:** Repackaging operations lack appropriate environmental controls.
*   **Cleaning Procedures:** Cleaning procedures are not validated.
*   **Warehouse Control:** Absence of defined areas or control systems in the warehouse.
*   **Investigations:** Failure to establish and follow written procedures for investigating critical deviations or out-of-specification (OOS) API batches. Investigations do not extend to associated batches. Critical deviations are not consistently investigated and resolved. Complaint investigations are not conducted to determine the cause.
*   **Test Methods & Lab Records:** Suitability of test methods is not verified under actual conditions of use and documented. Laboratory control records lack complete data from all tests (Repeat Observation).
*   **Specifications:** Specifications, sampling plans, and test procedures are not scientifically sound or appropriate for raw materials, intermediates, APIs, and packaging materials.
*   **Stability Studies:** Stability studies are not conducted to justify expiration/retest dates for repackaged APIs in different containers/closures (Repeat Observation).
*   **Quality Unit:** The Quality Unit does not review and approve all appropriate quality

## Related Documents

- [483 - 2019-03-12](https://www.globalkeysolutions.net/records/483/spectrum-laboratory-products-inc/51ba0d4f-2eac-4847-b63d-70482fd924fe)
- [483 - 2021-07-14](https://www.globalkeysolutions.net/records/483/spectrum-laboratory-products-inc/27b23f63-3a13-4e8d-a9b5-690c49298ae2)
- [483 - 2021-07-14](https://www.globalkeysolutions.net/records/483/spectrum-laboratory-products-inc/22ea7a36-9ac2-4abb-b23a-fac367b6828c)
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- [483 - 2025-02-19](https://www.globalkeysolutions.net/records/483/spectrum-laboratory-products-inc/2fcf91c3-69ae-4084-bc90-93ca7d348e90)

## Related Officers

- [Senior Compliance Officer](https://www.globalkeysolutions.net/people/barbara-wilimczyk-macri/36eda42e-09b6-4364-a000-c5cd8ddb70ee)
- [Investigator ](https://www.globalkeysolutions.net/people/sayyem-h-akbar/888c6b1b-7a62-4674-a73b-687c459db2f8)

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

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