The QMN Weekly Bulletin
Pharmaceuticals / Inspections and Audits

Amneal Handed 483 for Faulty Cleaning, Quality Procedures

Jan. 12, 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.

Written procedures for cleaning and maintaining equipment and utensils used in the manufacturing of drug products were not followed, according to the report. Metal detectors were observed without cleaning procedures and safety instructions. In addition, devices were not fully covered in an equipment storage room, a stainless steel scoop did not have a bag, and there were no cleaning procedures for multiple items in the room.

The agency also observed sanitation issues during the inspection. The investigator found a dead insect on the floor of the facility’s pharmacy room, and determined that complete cleaning was not possible because of rusted filing cabinets, packaging components and various materials throughout the room.