The QMN Weekly Bulletin

German devicemaker I.E.M. was hit with a warning letter after FDA investigators found shortcomings with corrective and preventive action (CAPA) procedures during a recent inspection of the company’s Stolberg, Germany, facility.

The FDA is bolstering the heparin supply chain with a draft guidance telling drugmakers to test each incoming shipment of heparin for species origin and contaminants, and audit each of their heparin manufacturers and handlers.

A new Form 483 for Novartis Consumer Health’s Lincoln, Neb., facility cites a litany of manufacturing failures and instances of tablets gone wild, with products found in odd areas of the plant’s packaging line — GMP deficiencies that prompted a nationwide recall.

The FDA has sued drug- and dietary supplement-maker Syntec and ordered U.S. marshals to seize its products, saying the company ignored warnings about false and misleading health claims.

Devicemakers can expect quality system audits to include a review of their postmarket surveillance procedures, including plans for any required clinical follow-up studies, according to a new European Commission guideline.

Concerns about an “unacceptably high risk” of cross-contamination of raw materials at a Nobilus Ent active pharmaceutical ingredient (API) facility has landed the company an FDA warning letter.

Undefined validation tests for key devices and a propensity to blame complainants when devices break has landed Numia Medical Technology an FDA Form 483.

Counterfeit versions of Genentech’s cancer drug Avastin are circulating in the U.S. supply chain after 19 practitioners bought the drug from an unauthorized foreign supplier, the FDA and the Swiss-owned drugmaker warn.