FDA upgrades standing of Jubilant U.S. sterile plant cited in 2013

In late 2013, Jubilant Life Sciences ran into trouble with the FDA over problems at its Jubilant HollisterStier sterile manufacturing plant in Spokane, WA, which the agency considered serious enough that it issued a warning letter. But after 18 months of work, the Indian company said the FDA has upgraded the plant's standing.

The Indian company reported last week to the Bombay Stock Exchange (BSE) that "The company's subsidiary, Jubilant HollisterStier, has been informed by the US Food and Drug Administration (USFDA) that its pharmaceutical sterile manufacturing facility in Spokane, Washington (USA), has been upgraded to the status of Voluntary Action Indicated (VAI)," The Economic Times reported. It said in its BSE filing that the improvement came after it had successful inspections in April and December of last year. A VAI classification is for objectionable conditions or practices that do not meet the standard of "regulatory significance."

"We consider this development as another step towards building a reliable and sustainable pharmaceutical business," Jubilant Life Sciences Chairman Shyam Bhartia said in the filing.

The 2013 warning letter noted that the 191,000-square-foot facility lacked appropriate written procedures to prevent microbiological contamination of products purporting to be sterile and that the agency wasn't satisfied with its system for cleaning and disinfecting aseptic processing areas and equipment. The letter points out that the company recalled some lots when it found unexplained increased levels of impurities and had to reduce the expiry of the product, but hadn't found the root of the problem.

In the same year, the drug company had received a warning letter for releasing lots from its plant in Kirkland, Québec, where it also manufactures sterile injectable products, even after some of the batches were out of spec. The inspector was told during the March 2012 inspection that the company "only inspects lots once regardless of the number of defective vial rejection rate."

- read the Economic Times story
- get FiercePharmaAsia's take

Suggested Articles

McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.

The FDA made public a voluntary recall of sterile injectables made by Coastal Meds of Mississippi, after visible particles were found in some vials.

It’s been a strange road for BMS' Opdivo-Yervoy combo in first-line kidney cancer, but the New Jersey drugmaker finally has a go-ahead.