US FDA slams cleaning procedures at Jubilant's Washington plant
Referencing an inspection in April and May of this year, the US Food and Drug Administration (FDA) sent the warning letter to the firm’s active pharmaceutical ingredient (API) supplier and contract manufacturing subsidiary, Jubilant HollisterStier, at the end of last month.
The Letter stated the firm had failed “to assure an adequate system for cleaning and disinfecting aseptic processing areas and equipment” was in place at the facility. The agency was particulalry critical of the firm's cleaning SOPs on the basis that they lack "provisions to ensure adequate use of sporicidal agents."
Jubilant was also criticised for its failure to establish appropriate written procedures in order to prevent microbiological contamination of drug products, including the validation of all aseptic and sterilization processes.
Furthermore, the manufacturer was pulled up over increasing levels of an unknown impurity in a product that the FDA did not reveal.
Lack of control
Though the FDA acknowledged Jubilant's appropriate response of withdrawing lots of the product from the market and reducing expiry dates, the FDA said: “It is essential that your firm also implement corrective actions to ensure the quality of the finished drug product throughout the product lifecycle.”
It continued: "Your firm does not appear to have adequate control of the [unspecified material]. Your firm cannot assure product quality by reducing the expiry without understanding the root cause of the increased [unspecified material]."
In a statement issued last week, the firm said it would be responding to the Warning by today and expected that “the on-going, manufacturing, distribution and sale of products from this facility will not be impacted as Warning Letter will affect new approvals only.”
The Letter is the second Warning for the manufacturer this year, with the FDA hitting its Quebec, Canada facility back in March.
