Shares of Divis Laboratories , on Friday, fell as much as 24 percent following reports of adverse observations from the USFDA made on its Vizag facility. The observations pertain to data integrity, improper controls and violations of current good manufacturing practices (cGMP). USFDA inspected the Unit-2 plant from November 29 to December 6 and issued a Form 483 with five observations.
The USFDA observations included proper controls not being exercised over computer systems. Other observations include: facilities and equipment were not maintained to ensure purity quality strength, while R&D division guides quality, production activities were inconsistent with CGMP. Failure to conduct proper probe with respect to complaints and documentation and records were not maintained properly.
Divis in its statement to stock exchanges on December 8 said it is responding to the five observations within the time permitted. The company did not disclose the nature of those observations at that time. Divi’s Unit-II plant in Visakhapatnam is located at Chippada village, about 35 km north of the port city. Divi’s is engaged in the manufacturing of generic active pharmaceutical ingredients or the key raw materials that go into the manufacture of formulation drugs, custom synthesis of active ingredients for innovator companies, other speciality chemicals and nutraceuticals.
The US drug regulator conveys its concerns on manufacturing practices through Form 483. Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly. If the company fails to meet the regulator’s expectations, a warning letter may be issued.
