Discussion forum for Pharma Quality events, Regulatory Actions

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

Janssen Vaccine Unit Warning Letter Flag

Janssen Vaccines Corp., a Johnson & Johnson company operating in Korea, was issued an FDA

Qvents Team
October 2, 2025

Janssen’s Korea Vaccine Unit USFDA 483

Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical

Qvents
February 26, 2025

Aarti Drugs USFDA 483 Flags Unique Chall

Authored by: Venkiteswaran.T.K, SubrangshuChourdhary, Srinivas Churya, Satish Reddy, Sanjeev Kumar Singh Aarti Drugs API facility in Tarapur, India

Qvents Team
December 16, 2024

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

IPCA USFDA 483: Poor Laboratory controls

IPCA Dhar facility was inspected by USFDA in June 2023. The site (FEI 3007574780) was

Qvents
July 13, 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

Eleven observations in USFDA 483 to IPCA

IPCA Ratlam (India) was issued USFDA 483 with 11 observations after inspection in June 2023

Qvents
July 3, 2023

IPCA USFDA 483 Cite Lapses in Data Integ

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/ USFDA Investigators: Rajiv Srivastava, Kellia

Qvents
June 1, 2023

IPCA USFDA 483 Flags Delayed Failure Inv

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/ USFDA Investigators: Rajiv Srivastava, Kellia

Qvents
May 29, 2023

IPCA USFDA 483 Highlight Criticality of

USFDA 483 / IPCA Laboratories, Silvassa, India / FEI 3005977675/ USFDA Investigators: Rajiv Srivastava, Kellia

Qvents
May 27, 2023