FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Eye Product Manufacturer Hit with Warning Letter

[ Price : $8.95]

FDA issues Regenerative Processing Plant a Warning Letter based on a 2023 inspection of the firms Palm Harbor, FL, manufacturing p...

Taenaka Kogyo Inspection Cites 4 Observations

[ Price : $8.95]

An April inspection of Japans Taenaka Kogyo ends in a four-observation Form FDA-483 that cites significant GMP violations.

Biocon Biologics Gets 10-item FDA-483

[ Price : $8.95]

FDA posts a Form FDA-483 issued to Biocon Biologics at the end of a July inspection at the firms Bengaluru, India manufacturing fa...

Patient Preference Info in Product Life Cycle

[ Price : $8.95]

FDA publishes a draft guidance on incorporating voluntary patient preference information in medical device total life cycle regula...

Info Collection on Pediatric Device Development

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection reinstatement entitled Yale-Mayo Clinic Centers of Excellence ...

Abbott Recalls FreeStyle Libre 3 Sensors

[ Price : $8.95]

Abbott Diabetes Care recalls (Class 1) three lots of its FreeStyle Libre 3 sensors after finding that a small number of them may p...

Medtronic Laryngoscope Recall is Class 1

[ Price : $8.95]

FDA says a July Medtronic recall of some McGrath MAC Video Laryngoscopes due to potential battery problems is Class 1.

Glenmark Pays $25 Million in False Claims Case

[ Price : $8.95]

The Justice Department says Glenmark Pharmaceuticals, a generic drug manufacturer in Mahwah, NJ, will pay $25 million to resolve c...

Breas Medical Recalls Vivo 45 LS Ventilators

[ Price : $8.95]

Breas Medical recalls (Class 1) its Vivo 45 LS ventilators to update the use instructions after internal testing identified the po...

Lilly Reports Positive Data in Weekly Insulin Trials

[ Price : $8.95]

Eli Lilly says data from two Phase 3 clinical trials evaluating once-weekly insulin efsitora alfa in adults with Type 2 diabetes s...