Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Warning letter to Jordans Amman Pharma:

FDA issued a Warning letter to Amman Pharmaceuticals following inspection at the facility (FEI 3013501887)

Chinese API Mfr Sichuan Deebio issued Wa

USFDA Inspectors Anders W. Evenson and Arsen Karapetyan had inspected the Sichuan Deebio facility (FEI

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

USFDA Untitled Letter To Nectar Cites De

Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies

Warning Letter to US Eye Drop Manufactur

The USFDA Warning letter to K. C. Pharmaceuticals issued in August 2023, following inspection at

Warning letter / Medgel / July 2023 / Fa

Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate

Warning letter / Medgel / July 2023 /Lap

Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate

Warning letter / Medgel / July 2023 / In

Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate

FDA issues Warning letters to several Fi

Several manufacturers of OTC drug products including mouthwash, toothpaste, topical analgesics, Sunscreen products, Hand Sanitizers