Indian manufacturer hit with Form 483 — again
An India-based generics manufacturer is once again feeling the wrath of US regulators.
Aurobindo Pharma has been slapped with a Form 483 following an inspection of the company’s oral manufacturing facility, the company announced in a letter, while keeping the details to a minimum.
The facility is located in Jadcherla, India, outside of the city of Hyderabad. The inspection began last week, and concluded on Tuesday, according to Aurobindo. The FDA noted six observations, though it’s still unclear exactly what went wrong.
Form 483 is issued when inspectors observed “any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts,” according to the FDA.
“The Company will respond to the US FDA within the stipulated timeline and work closely with US FDA to close the observations,” Aurobindo said in the letter.
The inspection is certainly not helping Aurobindo’s stock price $AUROPHARMA which fell over 2% today and has dropped more than 20% in the past year.
However, this is not the first time the company has found itself in the FDA’s crosshairs. The company has received 14 other 483 forms for different manufacturing sites in Telangana state since 2016.
In April of this year, FDA inspectors closed Aurobindo’s Dayton, New Jersey site, eliminating 99 jobs in the process. The site received a major warning letter in 2020, revealing that the company’s staff had failed to investigate unexplained discrepancies or failures in API batches and left water leaks in packing rooms, where ambient moisture can potentially contaminate APIs. The company was also accused of failing to identify impurity results from contamination due to mortar.
Aurobindo’s products have also been the target of several FDA recalls. Back in February, the company had to recall more than 1.15 million bottles of Moxifloxacin Ophthalmic Solution — an antibiotic used to treat eye infections like bacterial conjunctivitis — due to failed impurities and degradation specifications, according to The Economic Times. And in January, Aurobindo voluntarily recalled a lot of polymyxin B for injection after a hair was found in a vial within the lot. That antibiotic is used to treat meningitis, pneumonia, sepsis, and urinary tract infections.
The FDA also issued a warning letter to the company in January for another drug manufacturing facility in Telangana state in connection with a previous inspection. The letter cited deviations from current good manufacturing practices for API.