Qvents

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

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

Zydus Jarod Facility Classified OAI

Zydus Jarod facility (FEI 3013712903) is classified OAI by USFDA in July 2024. The USFDA

Sagent recalls Docetaxel Injection for p

Sagent is recalling two lots of Docetaxel injection in US. The recall follows a customer

Par Pharmaceutical recall Treprostinil I

Dublin based Par Pharmaceutical, part of Endo International plc is recalling one lot of Treprostinil

USFDA 483 to Laurus: Lapses in investiga

Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators

USFDA 483 / Intas / May 2023 /Failure to

USFDA 483 to Intas cites lapses in investigation and review of failures and discrepancies in

USFDA 483 / Intas / May 2023 /Manipulati

USFDA483 to Intas cites manipulated visual inspection reports; failure to characterise particles observed in injection

Accord USA has initiated recall of multi

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

Intas FDA 483 cites Manipulation of reco

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