Shredded records and unofficial spreadsheets land Italian plant with FDA warning

By Dan Stanton contact

- Last updated on GMT

Image: iStock/salajean
Image: iStock/salajean

Related tags: High performance liquid chromatography, Chromatography, Fda

Data integrity issues have landed Italian drugmaker FACTA Farmaceutici with a US FDA warning letter.

The letter​ published today was sent to the firm earlier this month following an inspection at the manufacturing facility in San Nicolo a Tordino, Teramo in January 2016.

The US Food and Drug Administration (FDA) observed a number of GMP violations at the plant, including discrepancies in data surrounding multiple sterile drug product lots.

“You stored original data in an ‘unofficial’ and uncontrolled electronic spreadsheet on a shared computer network drive,”​ the Agency said.

“Your analyst stated that original data was first recorded in this ‘unofficial’ spreadsheet and transcribed later to an ‘official’ form. This spreadsheet showed failing results above the limits you established in your procedure, PCH 035 Visible Particle Determination in use prior to September 1, 2014.”

The Agency also took issue with FACTA’s quality control unit, after observing numerous copies of uncontrolled blank and partially-completed cGMP forms without any accountability or oversight.

“For example, a supervisor said he photocopied a blank OOS form and transcribed the information because he had made mistakes in the original document,”​ the FDA said.

Furthermore: “Our investigator documented that your employees used paper shredders to destroy critical laboratory and production records without the appropriate controls and procedures. Shredded documents included High Performance Liquid Chromatography (HPLC) chromatograms and a partially-completed OOS form.”

As such, the FDA recommended the firm provides a comprehensive investigation into the extent of the inaccuracies in data records and reporting, a current risk assessment of the potential effects of the observed failures on the quality of drugs, and a management strategy that includes the details of your global corrective action and preventive action plan.

Related topics: Regulatory & Safety, Regulations, QA/QC

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