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 “the responsibilities and procedures applicable to the quality control unit are not fully followed. The written stability testing programme is not followed.”
‘Correctable, procedural’
Natco Pharma said the six observations, received after the inspection – conducted between January 16 and 24 – were, however, “correctable and procedural”. The company believes that the observations are minor in nature, Natco Pharma said in a release. “The observations are related to complaint and incident investigations, stability backlog and procedural SOPs.
“The company will provide due justifications and corrective action plan within the next 15 working days,” the drugmaker said. In another observation, the U.S.FDA said the “laboratory controls do not include the establishment of scientifically and sound and appropriate specifications and test procedures designed to assure that components, labelling and drug products confirmed to appropriate standards of identity, strength, quality and purity.”
The regulator also pointed to non-submission of an NDA field alert report within three working days of receipt of information concerning an incident that caused a drug product or its labelling to be applied to another article.
Another observation was about “procedure designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.” The regulator also observed that the disposition status of approved and quarantined drug product is not well controlled or identified.
The same Kothur unit of Natco Pharmahad also received a Establishment Inspection Report (EIR) from the U.S. FDA last August. after an inspection. between Febr uary 29 and March 7 that this year. The facility predominantly caters to regulated international markets, including the US.
