Pharmaceutical company Ipca Laboratories announced that its formulations manufacturing facility in Pithampur, Madhya Pradesh has passed a quality inspection by the US Food and Drug Administration (USFDA) and received a Voluntary Action Indicated (VAI) status.
A VAI status implies that the USFDA found certain non-critical issues at the facility which require remedial action from the company. However, the overall state of compliance at the facility is considered minimally acceptable as per USFDA standards. This is a positive development for Ipca as it clears the way for continued supply of products from this facility to the US market.
The inspection was conducted between June 15-23, 2023 at facility that manufactures a range of formulations including tablets, capsules, ointments and liquids which are supplied to both domestic and export markets.
VAI is one of the best outcome a company can expect from a USFDA inspection. Other more serious classifications like Official Action Indicated (OAI) would hamper ability to supply to the US. VAI status indicates only minor procedural lapses or documentation issues were found at the facility. No critical manufacturing or quality issues were identified.
Ipca now needs to submit a corrective action plan to the USFDA indicating how it will address the observations made during the inspection. If the USFDA is satisfied with the company’s corrective plan, the facility will continue to be classified as VAI. No restrictions will be imposed on product supplies to the US. The development is positive for Ipca as its key formulations facility has cleared a crucial regulatory hurdle. The company can now focus on growing its US generics business.
The company needs to comprehensively address all the observations made by the regulator during the inspection. Ipca needs to make necessary procedural or documentation improvements and may require training of staff and improving quality control processes.
The company can leverage the VAI status to register and launch more products from Pithampur facility in the US market.
