Discussion forum for Pharma Quality events, Regulatory Actions

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

Feb 27 test

testing

Qvents
February 27, 2025

Test 26 feb 123456

asdd test 123

Author Test
February 26, 2025

USFDA 483 / UCB Farchim SA/ June 2023 /

USFDA Inspected UCB Farchim site at Bulle, Switzerland (FEI 3005023799) in June / July 2023.

Qvents
October 30, 2023

USFDA 483 / UCB Farchim SA/ June 2023 /

USFDA 483 / UCB Farchim SA/ June 2023 / Gaps in Data Integrity program, lack

Qvents
October 30, 2023

USFDA 483 / IPCA / June 2023 /Inadequate

IPCA unit at Dhar, Madhya Pradesh, India USFDA 483 cites Invalidation of OOS with inconclusive

Qvents
August 2, 2023

USFDA 483 / Intas / May 2023 /Failure to

USFDA 483 to Intas cites lapses in investigation and review of failures and discrepancies in

Qvents
July 24, 2023

USFDA 483 / Intas / May 2023 /Manipulati

USFDA483 to Intas cites manipulated visual inspection reports; failure to characterise particles observed in injection

Qvents
July 24, 2023

USFDA 483 / IPCA / June 2023 /Failure of

USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim

Qvents
July 7, 2023

USFDA 483 / IPCA / June 2023 /Failure in

USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim

Qvents
July 6, 2023

Warning letter (2019) / Cadila, India /

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

Qvents
June 23, 2023