IPCA Laboratories Ltd. was recently under the radar when it announced last month that its Piparia facility in Silvassa received a Form 483 with three observations from the US drug regulator.
CNBC-TV18 has now accessed the Form 483 that was issued to the Piparia facility after the United States Food and Drug Administration (USFDA) conducted the inspection at the unit from April 18 to April 26.
According to the Form 483, the first of the three observations was IPCA Labs’ failure to thoroughly review any unexplained discrepancy.
The second observation was that responsibilities and procedures applicable to the quality control unit were not in writing and were not fully followed. And the third observation was that IPCA Labs failed to establish an adequate quality control unit at the Piparia facility.
Notably, the Piparia facility is IPCA Labs’ formulations manufacturing unit. The facility is already under import alert since March 2015 along with the company’s two other facilities at Pithampur and Ratlam.
In an exchange notification on 27 April informing about the Form 483, IPCA Labs had said, “The company will submit its comprehensive response on these observations to the USFDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest.”
The USFDA issues Form 483 to a pharma company’s management at the conclusion of an inspection when investigators have observed conditions that in their judgment may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and other Acts or regulations.
