Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in a newly published rebuke by the U.S. FDA.
In a warning letter dated Feb. 26, the FDA upbraided Granules over a slate of production shortfalls at its production facility in Telangana, India, including subpar cleaning, building maintenance, equipment upkeep and more. The agency posted the letter to its website Tuesday.
Granules previously received and responded to an FDA Form 483 following the agency’s visit to the plant from Aug. 26 to Sept. 6, 2024. The escalation from a Form 483 to warning letter suggests the FDA found Granules’ remediation efforts inadequate.
Regarding the facility’s hygiene, FDA inspectors uncovered “significant contamination” of machinery used for finished drug products. Granules installed filters to prevent such contamination, though “inadequate cleaning and maintenance processes” rendered these efforts moot, the FDA said in its warning letter.
What’s more, swab samples from certain equipment ducts revealed residue from multiple previously manufactured drug batches, the FDA said.
Beyond its equipment, Granules failed to keep the Telangana facility itself in good repair, the FDA pointed out. Notably, FDA investigators observed bird droppings and feathers near the plant’s air handling unit.
In its Form 483 response, Granules admitted that birds were entering the facility through “numerous gaps in the exterior walls," and it subsequently put up netting to block the entry point. That said, the company failed to assess similar vulnerabilities elsewhere in the plant, and the netting wasn't effective at preventing insects from entering the premises, the FDA said.
While those equipment and infrastructure problems made up the bulk of the FDA’s criticisms, the regulator also raised concerns with Granules’ manufacturing records.
During the inspection, the FDA says it discovered a “large amount of torn CGMP records,” including analytical balance printouts and testing data worksheets, in at least 15 plastic waste bags.
When confronted with the issue, Granules stressed that the documents had no bearing on product quality and offered multiple possible excuses, including a lack of familiarity with data integrity protocols and employee misinterpretation of established procedures.
Last month, Granules said it plans to enter the contract manufacturing field through its $22.3 million acquisition of Swiss peptide specialist Senn Chemicals.
“By entering the rapidly growing peptide therapeutics segment and acquiring CDMO capabilities, we are expanding into next-generation therapeutics that align with our commitment to innovation and affordability,” Krishna Prasad Chigurupati, Granules’ chair and managing director, said at the time of the announcement.