Tag: USFDA 483

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

USFDA 483 to Biocon Points Lapses in Equ

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

Deficient Method Validations, Aseptic ar

Cipla facility at Verna, Goa was audited by USFDA during June 2024 ending with issuance

Data Integrity issues, Delayed records:

USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site

Sun Pharma Dadra USFDA 483 cites Lack of

Sun Pharma Dadra unit (FEI 3004561553) was inspected by USFDA in December 2023 by FDA

Eugia USFDA 483 Cites Inadequate Contain

Aurobindo arm, Eugia Pharma Specialities facility at Bhiwadi, Rajasthan was issued USFDA 483 with seven

Zydus Vadodara USFDA 483 cites Contamina

USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.

Cipla Patalganga USFDA 483 highlights Cl

USFDA inspection of Cipla, Patalganga site manufacturing APIs and Tablets resulted in USFDA 483 with