Discussion forum for Pharma Quality events, Regulatory Actions

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

USFDA Warning letter to Centaur Pharmace

Centaur Pharmaceuticals, India issued Warning letter by USFDA. The Warning letter dated 5 June 2023

Qvents
July 19, 2023

EMA, the European Commission (EC) and th

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

Qvents
July 19, 2023

USFDA 483 of Catalent, Bloomington, USA

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

Qvents
July 17, 2023

Accord USA has initiated recall of multi

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

Qvents
July 17, 2023

IPCA unit at Dhar, Madhya Pradesh, India

Failure to thoroughly review unexplained discrepancies. Out of specification results on multiple batches of tablets

Qvents
July 13, 2023

FDA publish the USFDA483 issued to Intas

Batch records do not include complete instructions and records Manual visual inspection records of parental

Qvents
July 12, 2023

FDA updates the Risk Based Site Selectio

Qvents
July 7, 2023

Strides recalls 2700 bottles of Losartan

Qvents
July 7, 2023

FDA withdraws approval Oxandrin (Oxandro

Qvents
July 3, 2023

IPCA Ratlam (India) issued USFDA 483 wit

Qvents
July 3, 2023