Simplifying Global Compliance
Items Tagged with 'GMP'
Wyeth will respond this month to Form 483 observations from an FDA reinspection of the company’s Guayama, Puerto Rico, manufacturing facility, the firm announced. Read More
The European Medicines Agency (EMEA) recently published draft guidance for industry on technical requirements for marketing authorization applications for human tissue-engineered products (hTEPs). Read More
The European Medicines Agency (EMEA) has released for comment draft guidance on acceptable limits of metal residues in drug substances and excipients (inert substances that aid in binding a pill or tablet). Read More
Philips Medical Systems is continuing discussions with the FDA over the company’s alleged deviations from current good manufacturing practices related to the production of its automated external defibrillators (AEDs), the firm told D&DL March 6. Read More
Health Canada has issued a final guidance on GMPs for medical gases. Read More
The medical device industry is catching up to other industries in the area of automation for more efficient manufacturing. Read More
Health Canada has issued a final guidance on good manufacturing practices for medical gases. Read More
After the FDA warned Tiara Medical Systems for several cGMP violations regarding its complaint-handling system, the company successfully responded to all agency citations, the FDA said. Read More
FDA investigators found that Apple Medical’s procedures regarding its Fischer Cone Biopsy Excisors (FCBE), which are gynecologic electrocautery devices, violated several cGMP regulations, the agency said in a recent warning letter. Read More
HemoSense's medical devices are adulterated due to cGMP violations regarding its complaint-handling and investigating system, an FDA warning letter said. Read More
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