Glenmark Pharmaceuticals Limited — FDA Warning Letter Findings

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Your firm failed to perform method validation (or verification, as appropriate) of test methods to…

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). A. There were several dissolution failures for potassium chloride extended-release (ER) capsules during stability testing. One of the potential root causes you described was the occasional “ (b)(4) ” of your incoming active pharmaceutical ingredient…

Your firm failed to follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)). You failed to follow your written stability procedure for your finished drug products. For example, you did not complete timely stability testing for approximately (b)(4) stability samples for U.S. commercial drug products within the stipulated timeline ( (b)(4) after sample pull). Stability testing was overdue by 3 months or…