FDA Cites API Facility in Barcelona for Deviations from CGMP

On Nov. 22, 2016 FDA sent a warning letter to Interquim, SA summarizing CGMP deviations found during a May 2–6, 2016 inspection of its API manufacturing facility in Barcelona, Spain. FDA noted problems with equipment construction and cleaning procedures, as well as inadequate stability data.

FDA said that, although the company had revised cleaning methods in response to residue from inadequate cleaning noted during the inspection, the response “is inadequate because you did not determine that the revised cleaning procedure was effective. In addition, you did not determine if your cleaning procedures are effective for all API that you manufacture on your non-dedicated equipment. You did not define the acceptance criteria for carryover of residues.”

Another problem found during the inspection was failure to demonstrate that repairs to interior surfaces of equipment did not affect API quality. FDA said the company had not reported a root cause for the problem or associated corrective actions and preventive actions.

FDA also noted a lack of stability data to support the retest period assigned to reprocessed API. “Without stability data for your reprocessed API, you cannot assure that your reprocessed API meets specifications throughout its assigned shelf life. This could adversely affect the quality of the drugs that your customers manufacture from your API,” wrote FDA in the letter.

Source: FDA