Drugmaker Laurus Labs on Friday said the maiden USFDA audit of its Unit 4 was completed without any observations.
Stating that the unit was inspected from July 8-12, the company said in a statement that the audit was completed and no Form 483 was issued. The Unit 4, located at Achutapuram SEZ, Visakhapatnam, is for active pharmaceutical ingredient.
Form 483 is issued by the U.S. health regulator on completion of its inspection of a unit to intimate the management of the objectionable conditions, observed by its team, that constitute violation of the law.
