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US FDA records violations at Biocon's Malaysian facility

Biocon Ltd. confirmed that the U.S. Food and Drug Administration recorded six violations at the company's facility in Malaysia.

The Indian biopharmaceutical company received a so-called Form 483 — a letter at the end of a U.S. FDA inspection that highlights violations of certain acts as per the regulator's judgment.

Biocon said it plans to address the violations raised.

The FDA previously conducted inspections at the company's manufacturing facilities in Bangalore, India. In May 2017, it issued a letter with 8 observations.

Some inspections were also carried out by the French National Agency for Medicines and Health Products Safety.

The inspections had prompted the company to withdraw drug approval applications for some of its medicines.