From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it.
Earlier this month, Granules was slapped with a Form 483 from the FDA following an inspection of its Telangana facility in India that ran from Aug. 26 to Sept. 6. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.
The FDA published the Form 483 on its website Tuesday.
Drugmakers are subject to Form 483s when FDA inspectors discover “objectionable conditions” at a facility that could result in potential manufacturing violations. The write-ups are often followed by the more serious consequence of a warning letter if the company at fault fails to clean up its operations.
One of Granules’ biggest offenses comes down to poor control over production records.
The FDA noted that on the first day of its inspection, investigators witnessed three trucks “full of scrap materials” attempting to depart Granules’ plant. Upon digging into these scraps, the FDA found remnants of signed and dated manufacturing documents such as analytical balance printouts, handwritten worksheets and a “large number” of “uncontrolled papers” that had been “torn into pieces and crumpled.”
When the FDA was doing a walk-through of Granules’ quality control laboratory, inspectors noticed cleaning personnel removing a large black “scrap bag” from the area. The bag, like the trucks, contained a “large number of torn and a few intact pieces of analytical balance printouts, pH meter printouts” and more, the FDA said in its write-up.
The FDA concluded Granules’ quality control unit had been dropping the ball by documenting manufacturing data on “uncontrolled white paper” and later disposing of the documents by tearing them into pieces and throwing them into trash bags.
Upon piecing together some of these scraps with the help of Granules’ employees, the FDA was told by the plant's quality unit management that the torn pieces contained records that “should not have been destroyed.”
Elsewhere, Granules struggled to keep its facility clean, free of pests and adequately guarded against cross-contamination incidents, the FDA said.
For one, Granules failed to clean equipment to effectively remove traces of drug substance from previous manufacturing runs, creating the potential for cross-contamination, FDA investigators noted in their report.
Further, the FDA observed a buildup of white to off-white powdery materials along with water droplets, wet surfaces and material hinting at potential bacterial, fungal and mold growth inside air purification units.
Upon inspecting the filters for some of these purification units, the FDA found they were “torn in many sections,” while Granules’ HEPA filters contained “apparent dust, powdery materials and wet surfaces.”
Investigators also found bird droppings and feathers on certain purification units and noted the walls surrounding some of Granules’ manufacturing equipment “were not secured enough to prevent birds from getting inside the facility.”
Granules isn’t the only company being written up by the FDA for its poor handling of data and quality issues.
In a separate Form 483 handed down to a Biocon Biologics plant in India this summer, the FDA noted that the company both failed to back up and overwrote manufacturing data predating April 25, 2024, hindering the agency’s investigation.
The FDA further chided Biocon for its failure to properly investigate batch discrepancies. The regulator pointed out that it found employees had “inappropriately changed set points for instruments” that affected monitoring alarms in a room used to produce a U.S.-bound drug product.
“The investigation found these inappropriate changes were made as a quick fix instead of addressing frequent maintenance issues,” the FDA explained in the Form 483.
The write-ups for Granules and Biocon come as part of a slew of Form 483s published on the FDA’s website this month.
Elsewhere, the FDA also scolded Japan’s Taenaka Kogyo, India’s Gland Pharma and Spain’s Laboratorios Farmaceuticos Rovi for various production infractions.