USFDA inspections back in full swing for Pharma Companies

USFDA plant inspections seem to be coming back strongly after a two-year hiatus, going by the just-concluded inspection at Zydus Lifesciences on March 10 and a warning letter to Aurobindo earlier this year, in mid-January.

USFDA officials commented in February 2022 that USFDA is keen on restarting pharma companies inspections, including surprise inspections in India.

USFDA could be set for a busy year in India as the backlog of redressals from previous inspections and pending applications for plants and products become pressing.

Earlier, the total number of USFDA plant audits for drug quality assurance in India peaked in 2019 at 239.

Another 80 inspections were completed in January-March 2020 prior to Covid and slid to 5 inspections in 2021.

The surge in audit inspections could be periodic or could also be linked to evolving standards in manufacturing.

Related Posts

ONESOURCE’s partner receives USFDA tentative approval for Semaglutide Injection

OneSource Speciality Pharma announced that its partner Orbicular Pharmaceutical Technologies (Orbicular), together with its U.S.-based front-end partner (the ANDA holder), has secured tentative U.S. Food and Drug Administration (FDA) approval…

Ajanta Pharma gets USFDA Form 483 with five observations at Paithan plant

Ajanta Pharma said the United States Food and Drug Administration (USFDA) has completed an inspection at its Paithan manufacturing facility in Maharashtra, conducted between 13 April and 21 April 2026.…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

ONESOURCE’s partner receives USFDA tentative approval for Semaglutide Injection

ONESOURCE’s partner receives USFDA tentative approval for Semaglutide Injection

Ajanta Pharma gets USFDA Form 483 with five observations at Paithan plant

Ajanta Pharma gets USFDA Form 483 with five observations at Paithan plant

Obesity drug market to gain as Indians pop the pill and Chinese bring more

Obesity drug market to gain as Indians pop the pill and Chinese bring more

Aurobindo Pharma Rs 800 Cr Buyback Opens Apr 23

Aurobindo Pharma Rs 800 Cr Buyback Opens Apr 23

Boehringer Ingelheim launches AI centre for pharma research in London

Boehringer Ingelheim launches AI centre for pharma research in London

Pharma exports rose 2% to over $31 billion in FY26 despite sharp decline in March

Pharma exports rose 2% to over $31 billion in FY26 despite sharp decline in March