Drugs

FDA Warns Indian API Maker Over Quality Lapses

FDA has issued a Warning Letter to Cdymax India Pharma Private Limited after inspectors uncovered sweeping CGMP violations at the company’s active pharmaceutical ingredient (API) plant in Bangalore. The 11/13 letter follows an April inspection during which agency investigators documented extensive failures in Cdymax’s handling of out-of-specification (OOS) results, laboratory incidents, and test-method validation. FDA said the lapses rendered the company’s APIs “adulterated” under federal law.

According to the agency, the plant recorded roughly 1,500 laboratory incidents since 2023 — including OOS results, equipment failures, and other significant analytical problems — yet repeatedly failed to perform adequate investigations or determine root causes. In many cases, the company invalidated failing data without establishing whether results reflected true manufacturing issues.

Cdymax’s written response, submitted after the April inspection, “was inadequate,” FDA said, pointing to inconsistencies and a lack of evidence that the firm had corrected systemic deficiencies in its investigation and CAPA processes.

FDA also found that Cdymax relied on numerous in-house test methods that were never validated — or, when required, verified against pharmacopeial standards. Even a recently submitted method-validation report for a starting material lacked sufficient data on robustness, precision, and suitability, the agency wrote.

Regulators directed the company to undertake broad, independent assessments of its investigation systems, CAPA program, laboratory practices, and OOS procedures; to conduct a four-year retrospective review of all lab incidents for U.S.-bound products; and to overhaul its method-validation program.

Although Cdymax has hired a CGMP consultant, FDA reminded the company that “executive management remains responsible for resolving all deficiencies and systemic flaws.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome