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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.
The European Medicines Agency (EMEA) recently published draft guidance for industry on technical requirements for marketing authorization applications for human tissue-engineered products (hTEPs).
The European Medicines Agency (EMEA) has released for comment draft guidance on acceptable limits of metal residues in drug substances and excipients (inert substances that aid in binding a pill or tablet).
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.
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.
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.
HemoSense's medical devices are adulterated due to cGMP violations regarding its complaint-handling and investigating system, an FDA warning letter said.