Alkem’s US site, three Aurobindo facilities found in unacceptable state of compliance

By PharmaCompass

2019-05-24

Impressions: 116 Article

Manufacturing compliance is back in news as the US Food and Drug Administration (FDA) classified more companies as OAI (short for Official Action Indicated). An OAI letter means the facilities are considered to be in an unacceptable state of compliance with regard to current good manufacturing practice (cGMP). This week, there was news that the American drug regulator classified three plants of Indian drug major Aurobindo Pharma as OAI, necessitating regulatory and administrative action.

The FDA’s action came after it inspected the company’s plants that make active pharmaceutical ingredients (Units 1 in Telangana and Unit 11 in Andhra Pradesh, India) and an intermediate facility (Unit 16, in Telangana) between January and March this year. This means the company won’t be able to secure approval for products in the future from the FDA, until it takes remedial measures.

Aurobindo has reportedly submitted its initial response to the FDA and is also sending further updates on the committed corrective actions.

Similarly, Alkem Laboratories’ manufacturing plant in St. Louis (Missouri, USA) was inspected by the FDA from January 14 to February 5 this year. The firm received eight observations. There was also news the company had received a letter from the FDA informing them that manufacturing of a product should be withheld until completion of the final evaluation by the agency.

Last week, Alkem informed the stock exchange that the FDA continued its inspection from February 6 to March 22, 2019, and classified the inspection as an OAI.

This news comes after Lupin’s two facilities in India and one in the United States were classified as OAI over the past two months.

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