Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Purified Water System Qualification and

The FDA inspected Colgate-Palmolive/Tom’s of Maine, Inc’s Sanford facility in the US in May 2024.

Sanofi’s API Facility in US Issued

The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,

FDA Warning Letter to Indoco Remedies Fl

Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical

USFDA Warning Letter to Akron Formulatio

The USFDA has issued a Warning Letter to Hyderabad-based OTC manufacturer Akron Formulations for critical

EUGIA India FDA483: Critical Data Integr

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

Stagnant water in Equipment duct, Microb

Sun Pharma initiated recall of several drugs manufactured at Dadra site (India) for cGMP deviation

FDA Untitled letter to Novartis: Signifi

FDA had issued USFDA 483 in December 2022 to Novartis US site at Morris Plains,

USFDA issues Warning letter to Intas; Ci

USFDA issued a Warning letter to Intas, Matoda, Ahmedabad facility (FEI 3003157498) on 21 November

Bayer recall one lot of Vitrakvi (larotr

Bayer is recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass

Natco Pharma USFDA 483 Lists Eight Obser

Natco Pharma (india) Kothur facility was inspected by USFDA in October 2023. The site (FEI