Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Warning letter (2019) / Cadila, India /

USFDA Inspection at Cadila Ahmedabad, India in April-May 2019 by Investigators Justin A Boyd, Thomas

USFDA 483 (Aug 2021) & Warning lette

Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August

USFDA 483 (Aug 2021) & Warning lette

Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August

USFDA 483 / UCB, Belgium / FEI 300390935

USFDA 483 to UCB Belgium cites fundamental gaps in document control  – uncontrolled forms for

USFDA 483 / IPCA Laboratories, Silvassa,

USFDA 483 to IPCA, Silvassa (April 2023) cites Failure of Quality Unit, Failure of Quality

USFDA 483 / IPCA Laboratories, Silvassa,

USFDA 483 to IPCA, Silvassa (April 2023) cites lapses in timely closure of failure investigations

USFDA 483 / IPCA Laboratories, Silvassa,

USFDA 483 to IPCA, Silvassa (April 2023) cites inadequacies and thoroughness in Out of specification

USFDA Warning letters, 483s, WHO Alerts

Potential contamination of drug products with Diethylene Glycol(DEG), Ethylene Glycol(EG) has severe consequences including fatality

USFDA 483 / Sun Pharma, Mohali, India /

USFDA 483 to Sunpharma, Mohali unit in Aug 2022 cites deficiencies in Chromatographic integration and

USFDA 483 / Sun Pharma, Mohali, India /

USFDA 483 to Sunpharma, Mohali unit in Aug 2022 cites deficiencies in Product Quality Reviews