Indoco Remedies’ Goa facilities receive ‘Official Action Indicated’ status from USFDA following inspection
The OAI status follows an inspection conducted by the US FDA in July 2024 and indicates that regulatory or enforcement actions may be recommended due to observed compliance issues.
The facility had been inspected by the USFDA in February 2023 and had received an OAI status in May 2023. Indoco is comprehensively working on the remedial action plan at the facility which will be completed by Q3 2024.
Also Read: USFDA conducts pre-approval inspection at Indoco Remedies’ Goa facility, issues ‘four observations’
Indoco had planned to inform the US FDA of the inspection readiness after the remedial action was completed. However, the US FDA visited the Facility in July 2024, while the remedial action was still in progress. Hence, the compliance status of the Facility received as ‘OAI’ dated October 10, 2024, remains the same.
Aditi Panandikar, Managing Director said, “We are working holistically towards meeting the expectations of the regulators and are committed to remain focussed on compliance to deliver products of high-quality standards.”
What is the Official Action Indicated
Given that violations found on-site require further administrative sanctions and mandatory corrective actions.
Also Read: Indoco Remedies’ two more units gets US FDA observations
Last week, Indoco Remedies received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets USP, 10 mg (OTC). This approval introduces a generic equivalent of Zyrtec Allergy Tablets, 10 mg, developed by Johnson & Johnson Consumer Inc.
The Cetirizine Hydrochloride Tablets will be manufactured at Indoco’s facility in the Verna Industrial Area, Goa. Cetirizine is commonly used to relieve symptoms of hay fever and other allergic conditions.
Shares of Indoco Remedies Ltd ended at ₹336.95, down by ₹5.65, or 1.65% on the BSE.
