cGMPs / Large Molecule

Aurobindo injectables facility hit with 483 due to cleanliness

Mar 05, 2018

Bloomberg

The U.S. FDA has issued nine observations after a February inspection of Aurobindo Pharma’s unit 4 formulation facility in Hyderabad, India.

The observations for the injectables facility relate to equipment and cleanliness, employees, quality control and computer controls, according to the FDA Form 483 reviewed by BloombergQuint. The issues go beyond procedural observations to include problems such as improperly sanitized equipment, untrained employees and a building that is not free from infestation.

Unit 4 is one of the most important plants for Aurobindo Pharma, contributing 15 percent of total U.S. sales. Several drug approvals from the facility are pending in the U.S.

Aurobindo Pharma will now have to respond to the U.S. FDA with corrective measures.

Read the Bloomberg coverage