FDA Cites Buenos Aires API Facility for Records, Equipment Calibration

The FDA rapped Umicore Argentina for violations relating to its control procedures and equipment calibration, following a May inspection of the API manufacturer’s Buenos Aires facility.

The investigators found the firm did not validate its cleaning for removal of chemical residues from equipment used for manufacturing APIs, noting that the company only performed cleaning validation to check for reduced bacterial load rather than for chemical residues.

The FDA investigators also found that the facility did not follow procedures designed to prevent microorganisms in products not required to be sterile and failed to identify organisms outside of the established action limits.