483s

Investigation Docs Outside EDMS, Hold Ti

Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Srinivas Churya Jubilant Generics Roorkee facility was inspected in January

Data Integrity, Cleaning Issues: Granule

USFDA inspected Granules India’s  Finished Dosage and PFI facility (FEI 3004097901) at Gagillapur Village, Hyderabad

Deficiencies That Lead to Officiation Ac

Five different facilities of Eugia across India and US were inspected by USFDA between December

Global Calcium USFDA 483: Critical Data

With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary The USFDA inspection

USFDA 483 to Torrent: Concerns on Handli

With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary, Veena Raj The USFDA Form

Eugia Bhiwadi Facility Classified OAI: W

The Eugia facility in Bhiwadi, Rajasthan, India (FEI 3009883410) was recently classified as OAI (Official

USFDA 483 to Biocon Points Lapses in Equ

Biocon Visakh (Biocon Biosphere Limited, FEI 30221 25340) was inspected by USFDA investigator  Brandy N

Zydus Jarod Facility Classified OAI

Zydus Jarod facility (FEI 3013712903) is classified OAI by USFDA in July 2024. The USFDA

Warning letter Sun Pharma Dadra Unit: In

Sun Pharma’s Dadra Unit was issued FDA Warning letter in June 2024, following critical observations

Sun Pharma Dadra USFDA 483 cites Lack of

Sun Pharma Dadra unit was inspected by USFDA in December 2023 by FDA investigator Pratik