FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Noven Pharmaceuticals Cited for Quality Deficiencies

June 13, 2018
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The FDA hit Noven Pharmaceuticals for noncompliances at its drug manufacturing facility in Miami, Florida.

The agency found the process qualification protocol for the firm’s transdermal product, Minivelle, lacked adequate data to support time-dependent manufacturing activities.

The facility’s program for evaluating quality attributes during in-process inspection failed to include examples of all potential critical or major defects necessary for a consistent and full inspection, the agency said in a Form 483 report. Critical defects for un-pouched units such as missing or incomplete adhesive were not recorded.

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