Drugs

FDA Cites Neeyaan for Process Validation and Quality-System Failures

FDA has cited Neeyaan LLC for multiple GMP deficiencies, including the firm’s failure to validate drug manufacturing processes, conduct cleaning validation and adequately test incoming raw materials.

In a just-posted untitled letter, FDA said the company failed to establish and follow adequate written procedures for production and process controls. During the inspection, FDA investigators observed manufacturing operations that had been stopped because of tablet sticking and breaking. When asked for process-validation data, the company acknowledged that validation had not been conducted. The agency also said Neeyaan manufactured and released lots of certain USP tablets in 2025 for export without conducting process validation.

Neeyaan’s proposed corrective actions, including process-validation studies, were inadequate because its protocols did not provide sufficient detail concerning manufacturing processes, batch selection and testing designed to establish product homogeneity, according to the letter. FDA also said the company had not provided an adequate protocol for proposed process validation.

Additionally, FDA determined that Neeyaan’s quality control unit did not adequately exercise its responsibility for ensuring that drug products complied with GMP requirements and established specifications.

The agency cited incomplete batch records, including missing drug-product and raw-material lot numbers; inadequate procedures for tracing raw materials and in-process materials; distribution-record deficiencies; and failure to establish and adhere to an adequate stability program.

FDA characterized the problems as systemic weaknesses in the quality unit’s oversight and said the company’s proposed corrective actions did not demonstrate how it would strengthen quality oversight. Because of the nature of the deficiencies, FDA recommended that Neeyaan retain a qualified CGMP consultant.

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