FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

San Diego Manufacturer Cited for Equipment Design

Sept. 20, 2019

An FDA inspection of Ajinomoto Althea’s San Diego, California sterile drug facility found serious problems with its equipment setup, including a filling machine conveyor belt that caused vials to fall off the belt.

The design of a filling machine’s conveyor belt caused product vials to fall sideways and led workers to intervene with gloves as the products traveled down the line.

An ISO 5 operator continuously moved falling filled, capped and crimped product vials to keep them standing, the investigator said. An ISO 6 operator engaged in the same behavior to keep the vials upright, and an operator in the classified and environmentally controlled area used forceps to adjust falling vials, according to the Form 483.

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