The FDA has been uncharacteristically quiet when it comes to dishing out citations and warning letters this year—until summertime, that is, when the regulator slapped a generics drug maker with a slew of complaints.
In its first publicly posted Form 483 in months, the FDA blasted Jubilant Generics for a slate of cleanliness, quality control and record-keeping issues at an Indian factory.
The drugmaker failed to keep its equipment tidy, dropped the ball on investigations of manufacturing mishaps—like a pen cap turning up in a tablet bottle—and failed to properly back up and secure its production data, among other manufacturing flubs, the agency said.
The regulator handed down its seven-observation write-up after inspecting Jubilant’s Haridwar, Uttarakhand, facility between March 2 and March 12.
The company doesn’t clean and maintain its equipment often enough to prevent malfunctions and contamination, the FDA said. On the first day of their inspection, FDA reps found residue on a piece of non-dedicated equipment that had been marked as cleaned for product changeover.
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A compression machine was also sullied with residue after product changeover cleaning, the regulator said. There appeared to be rust on parts of one machine, while another piece of equipment featured “blackish stains,” the FDA added.
Jubilant’s cleaning regimen failed to account for all “hard to clean locations,” and its validation program only looked at large-volume equipment, the FDA went on to say.
Meanwhile, Jubilant didn’t conduct a thorough investigation after a manufacturing error prompted a recall, the FDA added. In November 2019, the company voluntarily pulled 100-mg amantadine hydrochloride in the U.S. after a complaint flagged the presence of a foreign particle in a lone compressed tablet.
The company didn’t investigate other batches with which it used the same visual inspection method to determine drug quality, the agency said, and those uninvestigated meds are currently at large on the U.S. market.
The FDA also gave Jubilant’s quality control unit flak for failing to suss out the cause of manufacturing errors. The regulator pointed to a pen cap that surfaced in a bottle of Jubilant tablets set to expire in December. The company determined that “insertion of a cap of pen into bottles is not possible at manufacturing site" because "existing controls are available at site to detect and reject the cap of pen in bottle,” as quoted in the FDA’s citation.
But the FDA says the company didn’t pinpoint potential deficiencies in its packaging line where foreign material might make its way into open bottles. The company also told the FDA that it doesn’t give its employees pens with caps, but the FDA said Jubilant failed to “limit the introduction of unapproved pens in your facility.”
Elsewhere, the company lacked adequate controls to ensure it’s making its drugs consistently. The company’s visual inspection process falls short of confirming that its automated tablet inspection equipment rejects out-of-whack tablets and capsules, the FDA said.
Since December 2019, the company has received 116 out-of-trend and out-of-specification results linked to an assay. Eight of those 116 batches underwent automated visual inspection. Meanwhile, the company has received seven lack-of-efficiency complaints in that same time frame, the FDA said.
Finally, Jubilant didn’t lock up its computer systems to ensure production and control records could only be accessed by authorized personnel, and it failed to back up data altogether in certain cases, the FDA said.
The company’s IT department uses a “pen drive” to back up manufacturing equipment data. Those data aren’t reviewed by the quality department before they are transferred to site backup servers. The FDA found inconsistencies in the backup data it reviewed from January 2019 through February 2020.
Jubilant isn't the first drugmaker knocked by the FDA for cleanliness and controls this year. Lupin's Novel Laboratories was slapped with a warning letter in July for a range of hygiene shortfalls at its Somerset, New Jersey, plant. The regulator has asked Novel Laboratories to overhaul its cleaning validation program after it discovered active drug residue from a previous drug on a tablet press, among other complaints.