The FDA hit Baxter with a Form 483 after multiple problems were discovered at its Valle del Cauca, Colombia facility during a June 4-8 inspection. Read More
The FDA cited Immunomedics for a host of violations – including its handling of a data integrity breach – observed at its Morris Plains, New Jersey, drug substance manufacturing facility between August 6 and 14. Read More
Seven months after issuing a Form 483 to MiBo Medical Group following an inspection of its Dallas, Texas facility, the FDA warned the devicemaker that it had not fully addressed the problems with design control procedures, CAPA procedure... Read More
FDA inspectors found shoddy process controls and a lack of validation documentation in a Sept. 17 to Sept. 21 inspection of Footprint Medical’s San Antonio, Texas facility. Read More
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