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