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The FDA warned DreamWest Innovations for failing to establish adequate design and testing files for its rapid intubation kits, making the products adulterated.
The FDA has warned Applied Water Engineering for manufacturing its dialysis devices without conducting quality audits or performing necessary complaint response procedures.
Bell-More Laboratories failed to properly maintain the building where it manufactures its drugs, allowing the products to become contaminated, an FDA warning letter said.
A clinical investigator recently received an FDA warning letter for implanting his experimental devices in 175 subjects without the proper informed consent forms.
Several recent FDA warning letters focus on violations by clinical investigators, ranging from informed consent failures to not getting required approvals and enrolling ineligible subjects.
The FDA warned Abraxis Bioscience for distributing pharmaceuticals that could have been contaminated during manufacture and for marketing drugs without approved new drug applications.
The Massachusetts Medical Device Industry Council (MassMEDIC) announced the launch of its coaching program for Massachusetts medical device startup firms.
The FDA sent a warning letter to Levitronix for several current good manufacturing practice violations, including failure to review complaints and set quality standards.