Simple, Cartoon-Friendly SOPs Lead to Higher Levels of Compliance: Experts
Succinct, simply worded standard operating procedures (SOPs) that can be expressed in cartoon or flowchart format lead to higher rates of compliance, pharma experts say.
Alexza CRL Followed 483 Citing Drug Storage, Training Lapses
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 Gets Closeout Resolving Clearance Concerns
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.
Contamination Crackdown Forces Some Chinese Drugmakers to Halt Production
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…
Indianapolis Helmet Maker Warned on Records, Procedural Flaws
The FDA has cited a manufacturer of cranial remodeling helmets on seven areas of documentation and policy flaws.
EMA Chided Over Lack of Transparency in Pediatric Trials Waiver Process
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.
API Maker NuSil Warned for Quality, Contamination Concerns
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 Handed 483 for Process Validation Lapses
Prosec Protection Systems, a maker of umbilical clamps, received a Form 483 for various process validation deviations at its Lakewood, N.J., plant.
Indianapolis Helmet Maker Warned on Records, Procedural Flaws
The FDA has cited a manufacturer of cranial remodeling helmets on seven areas of documentation and policy flaws.
Physicians Could See More Medical Devices Going Mobile
If all goes as the wireless health industry plans, it can start introducing far more products that allow physicians to monitor patients with no wires attached.
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