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June 15, 2018

Vol. 10 No. 24

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Noven Pharmaceuticals Cited for Quality Deficiencies

The FDA hit Noven Pharmaceuticals for noncompliances at its drug manufacturing facility in Miami, Florida. Read More

Taiwan Biotech Called Out for Environmental Monitoring

The FDA warned finished drugmaker Taiwan Biotech for significant CGMP violations at its facility in Taoyuan City, Taiwan, including inadequate environmental monitoring. Read More

Cincinnati Device Developer Hit for Complaint Handling, CAPA Issues

The FDA handed MHC Medical Products a Form 483 after its January inspection revealed multiple deficiencies at its Cincinnati, Ohio facility, including poor complaint handling and management, CAPA issues and procedural shortcomings. Read More

WAVi Dinged for Design History Files, Device Master Records

The FDA flagged problems with equipment calibration, design history files and record-keeping at the WAVi facility in Englewood, California. Read More