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US FDA raises concerns about Aurobindo's sterile formulations plant in India

The U.S. Food and Drug Administration raised concerns about one of Aurobindo Pharma Ltd.'s sterile formulations plant in India.

The regulator issued the plant with a form 483 — a letter outlining violations. The plant is located in Pashamylaram, Hyderabad.

In the letter, the FDA listed nine observations, citing serious deficiencies in maintaining the manufacturing quality standards, India's Business Standard reported.

The FDA listed certain violations including poor maintenance of equipment and premises among other quality issues at the site, and problems in procedures that are supposed to prevent microbiological contamination of sterile products.

Aurobindo said it was responding to the observations, none of which are related to data integrity or repetitive in nature.

The company received a Form 483 for another sterile manufacturing plant in nearby Bachupally in 2017.