The QMN Weekly Bulletin

Prosec Protection Systems, a maker of umbilical clamps, received a Form 483 for various process validation deviations at its Lakewood, N.J., plant.

NuSil Technology, a California-based maker of active pharmaceutical ingredients (APIs) and industrial silicone products, has been warned for specification testing shortfalls and microbial contamination concerns related to its simethicone emulsion USP.

An FDA advisory panel voted 6–4 late last month, with one abstention, against recommending approval of a new indication for Janssen’s oral anticoagulant Xarelto in patients with acute coronary syndrome (ACS).

The EU Ombudsman June 4 criticized the European Medicines Agency’s (EMA) lack of transparency and guidelines for deciding when to require drugmakers to carry out pediatric clinical trials.

The FDA has cited a manufacturer of cranial remodeling helmets on seven areas of documentation and policy flaws.

AkzoNobel Chemicals’ Mexican manufacturing plant has received a closeout letter, resolving a 2011 warning letter for failure to investigate and prevent shipment of contaminated products.

Several drugmakers in China are being ordered to power down production lines and hand over their licenses for producing capsule-based drugs after a crackdown on chromium contamination by the country’s regulatory agency.

Branan Medical, a maker of drug testing kits, received an FDA closeout letter resolving myriad marketing clearance and manufacturing concerns cited in a 2009 warning letter.