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The FDA handed Siemens Healthcare Diagnostics a Form 483 for violations including inadequate documentation of corrective actions and substandard complaint-handling procedures. Read More
A contact lens manufacturer that failed to respond to a Form 483 in February following an FDA inspection now must respond to a warning letter. Read More
Manufacturers planning to participate in the Medical Device Single Audit Program should first study up on Australian and Brazilian regulations, an official at the first company to go through a MDSAP audit tells GMP. Read More
The FDA handed Encompas Unlimited a warning letter for failures in quality control, implementation of medical device reporting procedures and incomplete device history records. Read More
Devicemakers can improve their facility inspection experience by engaging in constructive conversations with agency investigators, an FDA official says. Read More
Amgen could not certify to an FDA inspector that it had evaluated a contractor that serviced its equipment, according to a recent warning letter. Read More