Dr. Reddy's scolded for maintenance shortfalls in new FDA Form 483 filing

It’s critical to keep your workplace equipment clean and calibrated—especially in the realm of pharmaceutical manufacturing. Now, Dr. Reddy’s failure to uphold those standards has landed the Indian drugmaker in hot water with the U.S. FDA, according to one of two new Forms 483 posted on the regulator’s website this week.

In a 10-observation write-up, the FDA chided Dr. Reddy’s for missteps around building and equipment maintenance, deficient quality control activities, mishandling of complaints and more. The agency handed down the Form 483 after inspecting Dr. Reddy’s production plant in Telangana, India, in late October.

Among the problems the FDA uncovered, investigators found Dr. Reddy’s workers weren’t cleaning equipment and utensils regularly enough to prevent contamination that could alter the safety and quality of drug products made at the facility.

What’s more, certain equipment used in commercial release and stability analysis failed to meet calibration specifications, FDA investigators said. In fact, over the last three years, Dr. Reddy’s has had to file 40 incident reports around lab equipment failing routine calibration specifications.

As for the plant’s physical structure, buildings used for manufacturing and processing were “not maintained in a good state of repair,” the FDA added. Specifically, the agency warned that core processing areas were not maintained adequately to prevent mix-up or contamination. Inspectors also noticed cracks along the walls of manufacturing rooms and in one spot, surface damage was “so severe” that wall covering got eroded, exposing the concrete surface underneath.

Dr. Reddy’s other slights revolved around lackluster quality control, deficient written specifications, failure to follow up on batch failures and discrepancies, as well as inadequate responses to written and oral complaints from customers.

Meanwhile, Dr. Reddy’s isn’t the only drugmaker in the FDA’s crosshairs. Another Indian pharma, Kilitch Healthcare India, has also found itself on the receiving end of a Form 483, following an FDA inspection of its Maharashtra plant in mid-October.

The 14-observation report flagged problems related to controls against microbial contamination, incomplete lab records, building maintenance and more.

Much like Dr. Reddy’s, FDA investigators found that production buildings at Kilitch’s site were “not maintained in a clean and sanitary condition.” Investigators noted cracks in walls, dust build-up on air vents, leaks, stagnant water, water stains and peeling paint, among other maintenance shortfalls.

Aside from those infrastructural problems, Kilitch was scolded for failing to complete batch control records, with the FDA noting the company didn’t record interventions during routine batch manufacturing. Further, the company’s written stability program for drugs, including those bound for the U.S., “does not include meaningful test methods,” the FDA said.

Kilitch was founded in 1978. These days, the company says it’s largely focused on Africa and has expanded its footprint across key countries on the continent. The company’s products include drugs like Roipar, an effervescent formulation of paracetamol for pain and fever reduction.

Earlier this month, Kilitch joined a parade of drugmakers recalling eyedrops over safety concerns that could lead to eye infections.

After a pandemic-related slowdown in inspectional activities, the FDA has largely resumed doling out warning letters and Forms 483 at a steady clip.

Earlier this month, Natco Pharma, also based in India, received a Form 483 after investigators found that the company did not clean or properly maintain equipment and utensils to prevent contamination.

Prior to that, several companies received write-ups from the regulator in October, including UCB and Samsung Biologics.