Natco Pharma Ltd today said that the US Food and Drug Administration has issued two observations to its formulation facility in Ramky SEZ, in Visakhapatnam after the regulator conducted an inspection, in an exchange filing.
"At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure," the company said in the filing.
The inspection took place from January 30 to February 3. According to Natco Pharma, the business is certain that it can address every observation in the allotted period.
The pharmaceutical business in Hyderabad creates, produces, and markets completed dosage formulations and active pharmaceutical components in nations including India, the US, and Europe.
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