483
Spectrum Laboratory Products, Inc.Spectrum Laboratory Products, Inc. – FDA 483, Mar 12, 2019
Record Details
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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ID · 51ba0d4f-2eac-4847-b63d-70482fd924fe
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