Spectrum Laboratory Products, Inc. – FDA 483, Mar 24, 2023

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