Devices

FDA Cites Saluda Medical Over GMP Deficiencies

FDA has cited Australian medical device manufacturer Saluda Medical Pty. Ltd. for deficiencies involving cleanroom controls, manufacturing procedures and adverse event reporting, according to a just-posted Form FDA-483 related to a 5/25 inspection of its facility in Macquarie Park, New South Wales.

In the three-observation Form FDA 483, investigators found that the company had failed to recertify an ISO Class 7 cleanroom used to manufacture Class 3 spinal cord stimulation devices since 1/2023. The agency also found that the cleanroom had not been recertified under working conditions pursuant to the company's procedures.

Inspectors additionally identified deficiencies in manufacturing controls for Evoke CAP12X Lead Extensions, including improper weld pull testing, inadequate documentation of test results and insufficient instructions for test equipment setup.

The third observation involved failures to submit medical device reports (MDRs) within the required 30-day period. FDA cited two reports submitted at least 59 and 55 days, respectively, after the company became aware of reportable events.

The agency noted that the company had continued to miss reporting deadlines despite closing a corrective and preventive action addressing late submissions in 2/2025.

FDA Warns Baxter Over GMP Issues at Injectable Drug Plant

FDA has issued a warning letter to Baxter International citing significant GMP deficiencies at its Round Lake, IL, manufacturing facility, including recurring cross-contamination involving cephalosporin antibiotics, inadequate sterile manufacturing controls, particulate contamination and failures to properly investigate sterility test results. The just-posted 9/29 Warning Letter, which followed

Senators Urge FDA to Crack Down on ‘Research Use Only’ Drugs

Sen. Jim Banks (R-IN) is leading a group of senators urging FDA to ramp up enforcement against online vendors using “for research use only” labeling to market unapproved drugs and active pharmaceutical ingredients (APIs) to consumers, citing growing concerns about counterfeit versions of Eli Lilly’s investigational weight-loss

FDA Guidance on Drug-Related Software, Labeling Requirements

FDA has finalized a guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software that outlines how prescription drug manufacturers should address software applications used with their products, including when claims about the clinical benefits of such software can be included in FDA-approved drug labeling. The guidance addresses mobile

Device QMSR Fears Easing: Panel

Industry executives and FDA officials who participated in a 10/19 panel at The MedTech Conference say initial industry concerns about the new Quality Management System Regulation (QMSR) and its implementation by FDA are easing as companies get more experience with inspections under the new protocol. A Regulatory Affairs Professionals

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FDA Warns Baxter Over GMP Issues at Injectable Drug Plant

Senators Urge FDA to Crack Down on ‘Research Use Only’ Drugs

FDA Guidance on Drug-Related Software, Labeling Requirements

Device QMSR Fears Easing: Panel