Concerns about inadequate drug storage and quality training at Alexza’s Mountain View, Calif., facility were cited by FDA investigators just weeks before the company received a complete response letter (CRL)…
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.
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…
The FDA has cited a manufacturer of cranial remodeling helmets on seven areas of documentation and policy flaws.
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.
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…
Prosec Protection Systems, a maker of umbilical clamps, received a Form 483 for various process validation deviations at its Lakewood, N.J., plant.