Feb. 23, 2018

Vol. 10 No. 8

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Bray Group Cited for Multiple Violations

The FDA issued U.K. drug manufacturer Bray Group a Form 483 after finding numerous violations during an inspection of the firm’s Faringdon, Oxfordshire facility, including problems with validations, sample testing, cleaning and maintenance. Read More

FDA Flags Legacy Pharmaceuticals for GMP Deficiencies

The FDA observed GMP deficiencies in an inspection of a Legacy Pharmaceuticals Switzerland facility, including problems with sterility, maintenance and discrepancy investigations. Read More

ZOLL Circulation Draws Form 483 for Complaint Files, Environmental Controls

The FDA citedd ZOLL Circulation for problems with its complaint files and environmental controls observed in an October-November 2017 inspection at its facility in San Jose, California. Read More

FDA Flags Seiler for Undocumented Changes, Lack of MDR Procedures

The FDA cited a St. Louis device manufacturer over CAPA procedures, failure to report all corrections and problems with complaint handling. Read More