Italian API manufacturer Icrom was hit with a ten-item Form 483 by the FDA for serious quality violations at its facility in Concorezzo, north east of Milan.
The agency officials observed winged insects on the ceiling and walls of the raw material sampling room. The facility itself was in disrepair, the agency said, noting gaps between the bottom of one building’s door and warehouse floor, as well as leaking overhead pipes used in a water system.
The investigators observed other risks of potential contamination caused by the company’s inadequate cleaning of equipment and rooms. For example, they noted a filter housing with white residue that was labeled “empty and clean.” They also noted a filter with rust inside and a notable amount of residue on a plastic cover that was protecting clean equipment.
The lengthy 483 also flagged quality unit shortcomings. Specifically, the company didn’t have written procedures for CAPAs or document management and control.