Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

EMA, the European Commission (EC) and th

EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out

USFDA 483 of Catalent, Bloomington, USA

Catalent USFDA 483 /Bloomington (FEI :3005949964)/ Inspection Dates: May 4-12, 2023 / Inspectors: Wayne Scifert,

Accord (Intas) recall Multiple Injection

Accord USA has initiated recall of multiple lots of Atropine Sulfate, USP 8 mg per

IPCA USFDA 483: Poor Laboratory controls

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

Intas FDA 483 cites Manipulation of reco

FDA published the USFDA483 issued to Intas site (FEI 3003157498) in Ahmedabad, India after inspection

Strides recalls Losartan Potassium table

Strides recalled 2700 bottles of Losartan Potassium USP 25 mg tablets in US for presence

Eleven observations in USFDA 483 to IPCA

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