FDA shines light on Indian manufacturer’s misgivings at one of its facilities
Last month, Indian drug manufacturer Aurobindo Pharma let the national stock exchange know that they once again invoked the ire of US regulators. Now the ‘Form 483’ shines a light on what exactly went wrong.
According to the form, several observations were made at Aurobindo’s Unit VII formulation plant in the village of Polepally, India during an inspection in early May.
Investigators found an unexplained discrepancy and a failure of a batch of its components to meet any of its specifications. The FDA found out specification (OOS) assay and dissolution results had led to the rejections of four tablet batches which were identified by a lack of control over compression machine settings.
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