FDA Threatens to Refuse Admission of Spain Company's APIs for Deviations from CGMPs
The Food and Drug Administration requested corrective action by a Spanish active pharmaceutical ingredient (API) manufacturing facility, in a warning letter dated June 20 and posted to the FDA website on July 10. In its letter to Encros S.A., FDA…
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said a July 11-15, 2011, inspection of company’s facility in Aranjuez, Spain, identified significant deviations from Current Good Manufacturing Pratices (CGMP) for the manufacture of APIs, including, among other things, a water system incapable of consistently producing purified water and failure to maintain buildings and equipment used in manufacturing. FDA said the company’s August 2011 response lacked sufficient corrective actions, and threatened to bar Encros’ products from entry into the U.S. unless corrective action is taken.