Import Alert Against Divi’s Laboratories May Be More Than Just ‘Procedural’
Form 483 observations against Visakhapatnam facility do not appear to be “procedural” in nature.
U.S. drug regulator raised concerns over testing standards, data integrity and cleaning procedures at drugmaker Divi’s Laboratories Ltd.’s Visakhapatnam Unit-2 facility that has been barred from exporting products to the American market.
At least three of the six observations in Form 483, handed when the U.S. Food and Drug Administration inspectors find any possible violation of manufacturing standards, are not entirely “procedural” as the company said in its exchange notification. BloombergQuint has obtained a copy of the form.
The inspectors found that Divi’s was not testing all batches/lots of API before they were released for distribution. The observation was made on batches manufactured as late as 2017. One observation relates non-contemporaneous recording of data, according to the form. Another one is about cleaning procedures leading to concerns of microbial bio-burden in the finished API (active pharmaceutical ingredient).
These "are not procedural observations" but exact repeats of what happened the last time (in 2016) and one of them about “data integrity and falsification” is strong, said Amit Rajan, managing director of Celogen Lifesciences and Technologies Pvt. Ltd., a pharmaceutical products maker. “(The one about testing) is very surprising. How can you ship an API without testing,” Rajan told BloombergQuint in an interaction.
The company is yet to respond to BloombergQuint's emailed queries seeking its comment on the observations and their impact.
The U.S. FDA had issued an import alert against Divi’s Laboratories in March and followed it up with a warning letter in May. Plants on the import alert list cannot export drugs to the U.S. The nine-day inspection from September 9-19 was to review corrective and preventive measures taken by the drugmaker in response to deficiencies highlighted in the last inspection. Post the re-inspection, the company was issued Form 483 with six observations.