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The warning letter cited GMP violations for finished drug products.
On Jan. 13, 2017, FDA issued a warning letter to Facta Farmaceutici S.p.A. following an inspection of the company’s facility at Zona Industriale Sant Atto, San Nicolo a Tordino, Teramo 64100, from Jan. 11–19, 2016. The warning letter cited GMP violations for finished drug products. According to FDA, the drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B) as a result of the company’s failure to conform to GMP in its methods, facilities, or controls for manufacturing, processing, packing, or holding.
The warning letter stated that Facta Farmaceutici S.p.A. “failed to ensure that laboratory record included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).” It was noted that the original spreadsheet showed multiple sterile drug product lots failing the visible particle determination test, with glass, metal, fibers, and other particles found to be out of specification (OOS); however, passing results were recorded and the discrepancy was not adequately explained by the company.
FDA also noted that Facta Farmaceutici S.p.A. “failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).”
The FDA investigator observed many copies of uncontrolled blank and partially-completed CGMP forms (e.g., environmental monitoring recordings, OOS forms, water testing sheets, and clean room entry and exit logs) without any accountability or oversight of the company’s quality unit, the warning letter stated. According to the investigator, employees destroyed critical laboratory and production records (such as HPLC chromatograms and a partially completed OOS form) in paper shredders, without the appropriate controls and procedures. FDA stated that such findings indicate that the company’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures.