Natco Pharma’s formulation facility at Kothur, near Hyderabad, has received six observations, including one on the quality system after a recent inspection by the U.S. Food and Drug Administration (USFDA). In its observations, the regulator said that the responsibilities and procedures pertinent to the quality control unit are not fully followed. The written stability testing programme is not followed. Natco Pharma said the six observations, received after the inspection that was conducted between January 16 and 24 were, however, “correctable and procedural”.
On receiving the correctable and procedural observations from USFDA for its Kothur facility, Natco Pharma share price surged over 6% at Rs. 702 today at NSE.
The company believes that the observations are trivial in nature. The observations are associated to complaint and incident investigations, stability backlog and procedural SOPs. The company will make available due justifications and corrective action plan within the next 15 working days.
In another observation, the U.S.FDA said that the laboratory controls do not comprise the establishment of scientifically and sound and appropriate specifications and test procedures designed to guarantee that components, labeling and drug products set to appropriate standards of identity, strength, quality and purity.
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