FDA hands India's Natco Pharma another 483, with eight observations cited
Indian manufacturer Natco Pharma has been hit with another 483, following an FDA inspection made at its pharma manufacturing facility, located at 509 228 Telangana, India, between Oct. 9 and Oct. 18 this year.
The 26-page inspection report was issued to the manufacturer on Oct. 18 and was published on Wednesday, outlining eight observations.
Equipment was not properly assigned to the correct personnel and was operated by unauthorized employees, including equipment used to manufacture batches of products for the US market, the Form 483 said.
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