Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistDiamond Chemical Co., Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of finished pharmaceutical drugs at its New Jersey facility during a May 2024 inspection. The company failed to conduct identity testing on components used in over-the-counter drug products, including the active ingredient ethanol, and improperly relied on supplier certificates of analysis without establishing the reliability of those suppliers' test methods at appropriate intervals as required by 21 CFR 211.84(d). These deficiencies rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act, and the company's response to the FDA's Form 483 observations was determined to be inadequate.