Shared Beta-Lactam Facilities: Achieving
Recent USFDA warning letter, issued to Baxter (October 2026), citing inadequate beta lactam contamination controls
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Recent USFDA warning letter, issued to Baxter (October 2026), citing inadequate beta lactam contamination controls
USFDA has issued a Warning Letter to Eurofins SF Analytical Laboratories, Inc, Contract Testing Laboratory
Amidst the heightened surveillance and enforcement actions initiated by different state licensing authorities (state FDAs)
The USFDA has released a new draft guidance, Container Closure Systems for Human Drugs and
Qvents provides useful tools for QMS processes – Risk Assessments, Continuous Process Validations, Supply Chain Traceability
The USFDA recently issued a warning letter to Intas Pharmaceuticals Limited (Dehradun facility, FEI 3005890633
Unichem Pharmaceuticals (USA), Inc. initiated a recall of Bisoprolol fumarate and Hydrochlorothiazide tablets in the
USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form
Imprimis NJOF recalled three intraocular ophthalmic injection drug products in December 2025 (as per USFDA
In November 2025, the USFDA issued a Warning Letter to Bangalore-based Cdymax India following an