Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA Issues Warning Letter to Global Ca

Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in

USFDA Flags Major cGMP Deviations at Une

New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch

Deficient Method Validations, Aseptic ar

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

Eudra GMDP lists Everest Organics and Ak

Everest Organics Ltd (Telangana, India) was issued a GMP Non-Compliance Report with recommendation to suspend

Zydus Vadodara USFDA 483 cites Contamina

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

EUGIA India FDA483: Critical Data Integr

Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb

USFDA483 to Aurobindo’s Eugia US Site

USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance

FDA 483 to UCB Switzerland cite gaps in

USFDA 483 issued to UCB Farchim SA, Switzerland site (FEI 3005023799) is published by FDA.

Warning letter to Intas, Ahmedabad after

Intas facility was inspected by FDA investigators Jose E Melendez, Justin A Boyd, Pratik S

IPCA USFDA 483: Poor Laboratory controls

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