IPCA Pithampur unit in minimally acceptable state of compliance by US FDA
USFDA issues EIR for Ipca Labs SEZ Indore facility
After a pandemic-fueled lull the past few years, FDA inspections are back in full force. This week, a pair of Indian drugmakers have found themselves in the agency’s crosshairs.
FDA Issues Form 483 to Ipca Lab India
Ipca Laboratories, an India-based maker of active pharmaceutical ingredients, was cited for several quality and testing issues during a recent FDA inspection.
FDA Issues Form 483 to IPCA Lab
The US FDA conducted the inspection of Ipca Laboratories Limited's formulations manufacturing facility situated at SEZ Indore, Pithampur (Madhya Pradesh) from 15th June, 2023 to 23rd June, 2023. At the conclusion of the inspection, US FDA has issued a Form 483 with 8 (eight) observations.
The FDA identified several quality issues at a plant in India owned by Ipca Laboratories that makes active pharmaceutical ingredients.
FDA Issues form 483 to Ipca Laboratories
The Central Drugs Standard Control Organisation (CDSCO) has declared almost five per cent of the drug samples it tested during the month of January as Not of Standard Quality (NSQ), including some of them labelled as manufactured by Sun Pharma Laboratories, Cipla Ltd, Torrent Pharmaceuticals, Glenmark Pharmaceuticals, Alkem Health Science, IPCA Laboratories and Eris Lifesciences, among others.