Morepen Laboratories secures fourth consecutive USFDA ‘NIL 483’ inspection

Zero-observation outcomes strengthen global credibility and accelerate CDMO ambitions

USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI

The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.

Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2

The company is addressing these observations comprehensively

Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1

Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume

Unichem receives Form 483 from USFDA with 3 observations for Roha API facility

The company will provide the necessary response to USFDA within stipulated 15 days

Piramal Pharma completes USFDA inspection of Aurora facility with Zero Form-483 observations

Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s

Raichur site is the group’s largest API facility and part of a wider network of seven sites

USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit

The observations issued are neither repeated observations nor related to data integrity

USFDA issues Form-483 for Piramal Pharma's facility at Turbhe

Observations are largely around improvement of procedures and practices

Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations

The inspection was carried out from January 28 to February 1, 2025