FDA blows up Indian manufacturer’s MD site for unsanitary conditions in Form 483 letter – Endpoints News

For the first time in over a year, the FDA has released a Form 483, and this time a Rockville, MD plant of Indian maker Jubilant Generics received the bad news.

In March, inspectors noticed residue residue on a compression machine used for three different batches of tablets, failing to prevent potential contamination. Drug residue and particles were found in the waste pipe and on the walls, and rust was found on the port of a machine used for six different drugs distributed in the United States.

Swab samples were also not collected from a number of surfaces rated as “hard to clean” by Jubilant, and the company has no reason why some surfaces were cleaned with less cleaners. effective in at least five cases.

“The quality control unit does not have the authority to review production records to ensure that no errors have occurred and to fully investigate errors that have occurred,” the FDA said in under observation 7. “Specifically, your quality control unit has failed to fully investigate errors that have occurred in order to support the root causes identified.

Jubilant also did not extend the investigation of a defective lot to other products that may have been associated with the failure. This dates back to 2019, in a case where the company recalled 100 mg amantadine hydrochloride tablets, used to treat influenza.

The recall was for a compressed tablet containing a “foreign particle,” the FDA said, but the investigation did not extend to other batches of products using the same AQL inspection analysis, despite the risk of critical defects in other batches of drugs. The company has repeatedly failed to establish a procedure that verifies the consistency of manufactured drugs, the FDA said.

“As of December 2019, all US products have undergone a 100% automated visual inspection,” the Form 483 states. “Your current visual inspection process does not ensure that non-compliant tablets and capsules are rejected.

Jubilant announced in June the expansion of its manufacturing of sterile injectables at its Spokane, Wash., Site with a $ 92 million investment that will increase capacity by 50%, the company said. It has a Covid-19 vaccine filling and finishing agreement with Novavax and an agreement with Eli Lilly for the manufacture of bamlanivimab at its Spokane plant. Its other manufacture is in Quebec, Canada.

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