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Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.
FDA sent a warning letter, dated July 31, 2019, to Spectrum Laboratory Products, Inc. after an inspection of the company’s New Brunswick, NJ facility found the site had not transferred all quality and regulatory information about its API manufacturer to its customers. The company had been previously cited for similar deviations at its facility in California.
According to the agency, during the inspection, which was conducted Feb. 19–March 12, 2019, it was discovered that names and addresses of original manufacturers of repackaged API were missing from certificates of analysis (CoAs) sent to the company’s customers. Spectrum responded to FDA that its customers can request information about the original manufacturer if they sign a non-disclosure agreement. FDA, however, stated in the warning letter that omitting this information compromises the supply chain. Industry guidance also states that API should be labeled with the identity of the original manufacturer.
The agency is requesting that the company provide a remediated program for generating CoAs, a retrospective review to determine if and how product may be affected, and examples of recently issued CoAs that include original manufacturer information.