Mold in a class 100 production room and holes in a ceiling at a CP Pharmaceuticals plant in Wrexham, U.K., are part of a list of violations identified by FDA inspectors in Warning Letter 320-11-002. The letter follows a July inspection. Because CP took more than 15 days to reply to the Form 483 report issued after the inspection, the regulator doesn't acknowledge them in the warning.
The mold and the holes are some of the building-related inspection details the FDA documents. Inspectors note the holes in the ceiling of a freeze dryer room and say they saw outside light entering in the vicinity of the ventilation system. The letter says the room is subject to regular maintenance, yet the holes remain despite an incident report from late last year that describes them. Another item from the incident report: bubbling vinyl and disintegration of the wall beneath it.
Inspectors found more mold in a class 10,000 area, almost a year after it was first seen there. The warning cites CP for lack of a schedule for cleaning with a spore killer.
- here's the warning letter