Discussion forum for Pharma Quality events, Regulatory Actions

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

Warning letter / Medgel / July 2023 / Fa

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

Qvents
August 23, 2023

FDA issues Warning letters to several Fi

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

Qvents
August 14, 2023

USFDA Warning letters, 483s, WHO Alerts

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

Qvents
May 10, 2023