Cloud over Sun unit

Sun Pharmaceutical Industries (Sun Pharma) on Friday said the US Food and Drug Administration (USFDA) had issued Form 483 that contains six observations after an inspection of its Halol facility in Gujarat.

By Our Special Correspondent
  • Published 8.09.18
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Mumbai: Sun Pharmaceutical Industries (Sun Pharma) on Friday said the US Food and Drug Administration (USFDA) had issued Form 483 that contains six observations after an inspection of its Halol facility in Gujarat.

According to the US health regulator, Form 483 notifies the company's management of objectionable conditions at the facility inspected.

In June, the USFDA had cleared the unit so that supplies could resume from that site. Subsequently, Sun Pharma had received its first drug approval in more than four years for the Halol plant from the US drug regulator.

However, the USFDA again conducted an inspection from August 27 to August 31, following which it issued Form 483 with six observations, Sun Pharma told the stock exchanges on Friday.

The company, however, did not provide details about the observations .

Reacting to the development, the Sun Pharma scrip slipped nearly two per cent on the bourses.