Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
Nephron Pharmaceuticals
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
Discoloration
Discoloration
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic aseptic process simulation and discovered bacterial growth in a number of media fill vials, exceeding the allowable limit.
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
Lack of Assurance of Sterility