The FDA issued a warning letter to Turkish drugmaker Deva Holding for serious violations in its penicillin production facility.
The facility, which manufactures penicillin, non-beta-lactam antibiotics and other drug products, is split between two campuses in Tekirdağ, west of Istanbul, one of which is used for producing penicillin. The agency inspected both buildings between Feb. 4-15 and found numerous contamination issues.
The agency noted that penicillin was frequently detected outside of the proper manufacturing areas, including in the personnel entrance to the building where the firm manufactures U.S.-marketed non-beta-lactam drug capsules.
“No safe level of penicillin contamination has been determined to be a tolerable risk,” the agency said.