Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

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

Cipla Warning letter cites gaps in Compl

The Warning letter (dated November 17, 2023) follows the FDA inspection at Cipla’s Pithampur, Indore

Cipla Pithampur unit gets FDA Warning le

Cipla in a statement informed that its Pithampur, Indore facility is issued an USFDA Warning

Warning letter to Intas, Ahmedabad after

Intas facility at Matoda, Sanand in India (FEI 3004011473) was inspected by FDA investigators Jose E

USFDA 483 to Cipla cites deficiencies in

USFDA inspection of Cipla Pithampur site ( FEI 3008581988) by Inspectors Saleem A Akhtar & 

Intas USFDA 483 cites Data Integrity, to

USFDA Inspection of Intas, Matoda, Sanand facility in India (FEI 3004011473); from 22 November 2022 to