Granules slammed in FDA warning letter detailing discarded documents, intruding birds at Indian plant
In a warning letter dated Feb. 26, the FDA upbraided Granules over a slate of production shortfalls at its production facility in Telangana, India, including subpar cleaning, building maintenance, equipment upkeep and more. Granules previously received and responded to an FDA Form 483 following the agency’s visit to the plant last year.
