Amphastar Pharmaceuticals, Inc.: BLA 761403

Due to the deficiencies identified in bioanalytical method validation and bioanalysis for insulin aspart quantitation as indicated on the FDA Form 483 issued on ae.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA Form 483 prior to your complete response to your application.

Your complete response should include the date(s) of the facility's response to the FDA Form 483. The assessment of application approvability and the resolution of inspection deficiencies would be evaluated upon receipt of the complete response and may include re-inspection of the facility.