Inspections News

Drug

Indian Drug Manufacturer Cited for Numerous Problems

A multitude of CGMP violations at Cadila Healthcare’s Ahmedabad, Gujarat facility netted the generics manufacturer a Form 483 from the FDA. Read More
Drug

German Drugmaker Cited for Inadequate CAPAs

The FDA hit German bulk drug substance manufacturer Dynavax GmbH with a Form 483 over seven violations seen at its Düsseldorf facility, including inadequate corrective and preventive actions (CAPAs). Read More
Drug

Pennsylvania Drugmaker Warned for Labeling and Testing Issues

FDA hit High Chemical Company with a warning letter over CGMP deviations for active pharmaceutical ingredients (API) it manufactured at its Levittown, Pennsylvania facility. Read More
Device

More Notified Bodies Give Up on EU MDR/IVD Certification

The shortage of notified bodies to certify devices for the new EU medical device and IVD regulations appears to be reaching crisis point as more notified bodies say they won’t be offering certification. Read More
Drug

North Carolina API Manufacturer Cited for Serious GMP Failures

The FDA hit API and repackaging facility Giles Chemical of Waynesville, N.C., with a lengthy Form 483 for multiple violations including the use of “reclaimed water” in manufacturing API products. Read More
Device

Process Change Lapses Lead to 483 for Wisconsin Firm

Failure to establish procedures for process changes as well as documentation and CAPA lapses led to a seven-item Form 483 for Performance Health Supply following an April 8-17 FDA inspection at its Cedarburg, Wisconsin facility. Read More
Drug

New Jersey Drugmaker Draws Warning Letter for Water System Violations

The FDA issued a warning to a Belleville, N.J. OTC drugmaker US Pharmaceuticals for serious failures in its purified water system including high microbial counts. Read More
Device

Lack of Process Validation Results in 483 for Wisconsin Devicemaker

A Feb 19 to March 12 FDA inspection of Preservation Solutions’ Elkhorn, Wisconsin facility revealed that the firm failed to correctly validate its aseptic processes for manufacturing and processing sterile organ transplant preservation solutions. Read More
Device

Pacific Medical Gets 483 for Spec Failure

Failure to investigate complaints that certain devices did not meet specifications resulted in a Form 483 for Pacific Medical Group of San Clemente, Calif., following a Feb. 6 to March 14 FDA inspection. Read More
Drug

FDA Cites Florida Compounder for Unapproved Drugs

Complete Pharmacy and Medical Solutions received a Form 483 from the FDA with seven observations stemming from a Jan. 9-23 inspection at its compounding facility in Miami Lakes, Florida. Read More