The Aurobindo injectable manufacturing plant, based in Hyderabad, India, received a Form 483 from the US Food and Drug Association (FDA) with nine observations last month.
A statement on the FDA website explained: "An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts."
Located on Hyderabad’s outskirts, the Unit-IV manufacturing plant is a facility for generic sterile injectables (lyophilised and powder injections, pre-filled syringes), ophthalmics and low volume parenterals.
Aurobindo has issued the following statement in response to the FDA's findings: "None of the observations are related to data integrity or repetitive in nature and we are in the midst of providing a comprehensive response to the observations and would be replying to the FDA within 15 working days from the date of closure (20 February, 2018) of audit."
Regulatory problems are piling up for the sterile manufacturing operations of India’s Aurobindo, which also had its Chitkul Village unit IV facility in Andhra Pradesh given a Form 483 last September describing two issues.
Its sterile manufacturing facility in Bachupally, Hyderabad, also received a Form 483 with six observations in April 2017, including problems in procedures that are supposed to prevent microbiological contamination of sterile products.
The findings come as the India drugmaker is expanding its biologics and sterile capabilities in the US and Europe.
Last year the company acquired four biosimilar products from Switzerland-based TL Biopharmaceutical and reported it was building a manufacturing plant to support the production of those and eight others it has under development.
The company also has several projects occurring in the US, including plans to build a second sterile injectables plant at its 567,000 ft2 sterile manufacturing facility in New Jersey.
The FDA opened its India office in New Delhi in 2008, aiming to ensure food and medical products exported from India to the US are safe, of good quality and are effective.
