Chromatography Institute of America dba Compounder’s International Analytical Laboratory — FDA Warning Letter Findings

Lack of adequate laboratory control mechanisms Your firm conducts chemical and microbiological testing of APIs, drug products compounded by outsourcing facilities registered under section 503B of the FD&C Act, and finished drug products for human and animal use. Records and information collected during the inspection demonstrate that you use the same methods and procedures whether you are testing APIs, drug products compounded by outsourcing facilities registered under…

Lack of adequate Quality Unit oversight Your Quality Unit (QU) failed to exercise adequate oversight over your contract testing operations. For example, your QU failed to ensure: Establishment of restricted access and appropriate controls on computerized systems to prevent any potential alteration or deletion of laboratory data. Implementation of an effective document control system for issuance, tracking, and reconciliation of CGMP documents used for laboratory testing and…

Lack of adequate investigations Your investigations into multiple failed sterility test results were inadequate. In 2024, you had nine drug product sterility test failures, for which your investigation concluded that the probable root cause was “technician error – environmental contamination.” However, your root cause was not supported by the environmental monitoring data on the dates when the failing sterility samples were prepared. You did not recover any microorganisms on…