Sun Gets 483 After FDA Spots Contamination Potential

Sun Pharmaceutical Industries has received a Form 483 for lacking procedures to prevent objectionable microorganisms in drug products.

During the inspection, FDA inspectors observed particles that appeared to be packaging material floating in bulk solution after the designated mixing time in a mixing vessel, the form says.

Additionally, there is no evidence that complaint investigations involving a specific drug were expanded to cover other lots of the same product.
Drug GMP Report