Author: Qvents

USFDA Warning letter to Intas Flags Inte

The USFDA recently issued a warning letter to Intas Pharmaceuticals Limited (Dehradun facility, FEI 3005890633

Qvents Apps and Tools For QMS and GMP Pr

Qvents provides useful tools for QMS processes – Risk Assessments, Continuous Process Validations, Supply Chain Traceability

USFDA Issues Guidance for Impurity Speci

The USFDA has issued a draft guidance for Establishing Impurity Specifications for Antibiotics in April

Responding to FDA Form 483: USFDA Issues

The USFDA has released a draft guidance titled “Responding to FDA Form 483 Observations at

Unichem Recalls Hypertension Tablets for

Unichem Pharmaceuticals (USA), Inc. initiated a recall of Bisoprolol fumarate and Hydrochlorothiazide tablets in the

USFDA 483 to Pharmathen Flags Deficient

USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form

Imprimis Recall Unapproved Ophthalmic In

Imprimis NJOF recalled three intraocular ophthalmic injection drug products in December 2025 (as per USFDA

Laboratory Incidents and Validation Fail

In November 2025, the USFDA issued a Warning Letter to Bangalore-based Cdymax India following an

Hetero USFDA Form 483: Unregistered Test

The USFDA inspection of Hetero Labs Ltd, Unit-IX (FEI: 3009093782), Narasapuram, India, conducted in September

Zydus Recalls Antipsychotic Drug for Nit

Zydus is recalling multiple lots of the antipsychotic drug Chlorpromazine in U.S due to the