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Pharmaceuticals / Inspections and Audits

Amneal Handed 483 for Faulty Cleaning, Quality Procedures

Jan. 11, 2018

The FDA hit Amneal Pharmaceuticals with a Form 483 over cleaning, sanitation and quality control issues after an October inspection of the drugmaker’s Paterson, New Jersey facility.

The FDA cited the firm for failure to follow quality control unit procedures, noting that the unit did not qualify multiple suppliers of products used in the facility’s drug manufacturing. It also neglected to follow its standard operating procedures for initialing and tracking quality and compliance actions.

The investigator also noted inadequate methods for cleaning and maintaining equipment. For example, a dirty rag was found inside the firm’s tablet press, and a yellow powder was found on equipment in the firm’s coating room, though the last product on the production line was white in color.

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