July 21, 2017

Vol. 9 No. 29

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IBA Molecular Cited for GMP, Quality Issues

A PET finished dose manufacturer in Ohio was cited by the FDA after investigators witnessed numerous cGMP violations and potential quality problems on a January site visit. Read More

FDA Hits Tubilux Pharma for Contamination Risks, Particulate Testing

Drugmaker Tubilux Pharma manufactured products in conditions that risked contamination and failed to properly test its products before release, according to the FDA. Read More

Full Range Rehab Cited for CAPA, Other Deficiencies

The FDA issued a Form 483 to Full Range Rehab citing problems with its CAPA procedures, acceptance activities, record-keeping and complaint handling. Read More

FDA Warns Ohio Devicemaker Over Validations, Complaint Procedures

Investigators found the facility’s complaint procedures did not include evaluating complaints to determine if an investigation was needed. Read More