Spectrum Laboratory Products, Inc. – FDA Warning Letter, Mar 12, 2019

The FDA issued a Warning Letter to Spectrum Laboratory Products, Inc. following an inspection of its New Brunswick, New Jersey, drug manufacturing facility from February 19 to March 12, 2019. The letter identifies significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering the firm's API adulterated under 21 U.S.C. 351(a)(2)(B). Key violations include the failure to transfer all quality and regulatory information from API manufacturers to customers and to reference the original manufacturer on Certificates of Analysis (COAs). The firm's response, proposing non-disclosure agreements or (b)(4) on COAs, was deemed inadequate, compromising supply chain accountability. Additionally, some repackaged and relabeled drugs were not listed with the FDA as required by 21 U.S.C. 360(j), making them misbranded. Specific API, including potassium bicarbonate and progesterone, were also misbranded under 21 U.S.C. 352(a) because their labels falsely represented Spectrum as the sole manufacturer (21 CFR 201.1(h)(2)). Similar CGMP deviations at another Spectrum facility indicate inadequate management oversight. The FDA requires a remediated COA program, a retrospective review of drug quality impact, and prompt corrective actions within 15 working days. Failure to comply may result in legal action, including seizure and injunction, and impact federal contracts or drug approvals.