One warning letter is bad enough, but when citations multiply across a company’s sites in just four years, a pattern starts to emerge.
FDA investigators are charging Lupin’s Novel Laboratories with a raft of cleanliness, consistency and quality control problems at a New Jersey factory despite a prior scolding from the regulator in November. Novel Laboratories’ manufacturing flubs are just the latest in a string of parallel offenses by parent company Lupin, the FDA said in a warning letter posted online this week.
During an inspection of the company’s Somerset, New Jersey, plant between September and November 2020, investigators found that Novel Laboratories failed to properly clean non-dedicated equipment, including a tablet press tainted with active drug residue from a previously made product.
Novel Laboratories ran analytical testing on the residue, but its efforts to correct the problem fell short because it needed to check for cross-contamination in reserve samples of distributed drugs manufactured on the equipment, the FDA said.
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The agency is now asking the company to draft improvements to its cleaning validation program, “with special emphasis” on “worst case” cross-contamination risks, including toxic and highly potent drugs, plus drugs that are difficult to clean and more.
After switching production to a new building, the company failed to validate manufacturing for 15-mg and 30-mg capsules of the sleep med temazepam, the FDA said. The company changed up processes and equipment then made and released drugs using the new procedures. Still, several batches have since been flagged for out-of-specification uniformity results, which suggest the company’s production process is “not robust,” the FDA added.
“You did not adequately demonstrate that your manufacturing processes are reproducible and controlled to consistently yield drugs of uniform character and quality,” the warning letter states.
The FDA dinged the company’s quality unit as well, noting certain cleaning procedures didn’t require adequate oversight from the quality team. Novel Laboratories was also behind on its annual product reviews at the time of the inspection late last year, the regulator said.
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Novel Laboratories previously made “corporate-wide commitments” to bolster its analytical method equivalency, cleaning procedures and APR across its sites, and said it would install corporate quality assurance oversight at those locations.
But to hear the FDA tell it, “[s]ignificant findings as detailed in this letter indicate that your QU is not fully exercising its authority and/or responsibilities.”
Novel Laboratories is just the latest Lupin site to find itself in the FDA’s crosshairs. The agency slapped two Lupin sites in India with a warning letter for similar manufacturing deficiencies in late 2017, after which the company made commitments to improve quality compliance and oversight across its network. A separate Lupin plant faced scrutiny in September 2019 for poorly cleaned manufacturing equipment and subpar process validation.
Those repeat violations paint the picture of a company whose “corporate oversight and control over the manufacture of drugs is inadequate,” the FDA said. The company needs to take a close eye to manufacturing operations and the meds it produces across all of its sites, the regulator said.
