FDA warns Italian drug manufacturer for quality lapses
- The Food and Drug Administration has tasked an Italian drug manufacturer with reviewing two years-worth of test reports after a January 2016 inspection questions the accuracy of the company's cGMP records.
- FACTA Farmaceutici S.p.A. failed to account for discrepancies between original data showing certain drug product lots failed inspection and subsequently reported data showing passing results, According to a recently posted warning letter.
- After flagging violations at 44 different companies last year, the FDA is off to a fast start again in 2017, issuing warnings to six companies (including FACTA Farmaceutici).
While warnings to Indian and Chinese manufacturers have become routine in recent years as the FDA cracks down, citations to European producers are less common.
The FDA's investigator found FACTA's record keeping to be below par, lacking controls over electronic data and proper processes to document failing results.
The inspection last year found blank and partially-completed CGMP forms scattered around the Milan, Italy site. Employees used paper shredders to destroy production records, the warning letter states.
"These findings raise questions about the effectiveness of your quality unit and the integrity and accuracy of your CGMP records."
The FDA tasked FACTA with evaluating all of its out-of-specification test results from January 2014 to January 2016 that were tied to the release of product.
So far this year, the FDA has cited issues at CTX Life Sciences, Porton BioPharma, Ningbo Zhixin Bird Clean-Care Product Company, Suzhou Pharmaceutical Technology and Sato Yakuhin Kogyo.
- FDA Warning letter
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