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.
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