FDA 483s: We Read’em So You Don’t Have To

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Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The FDA is taking its act overseas – and isn’t liking some of what it found.

The latest batch of 483s has a decidely international flair: Italy, Japan and Canada had the pleasure of hosting FDA inspectors in recent months. Three foreign firms were found wanting by the agency in a number of areas.

In the land of Christopher Columbus, and the birthplace of artificial hearts and artificial insemination THD S.p.A., a maker of rectoscopes, anescopes, proctoscopes and Doppler systems devices, was issued a March 26 warning letter for failing in several cGMP areas. For example, the FDA inspector cited a failure to:

  • Establish and maintain procedures for receiving, reviewing and evaluating complaints by a formally designated unit.
  • Review and evaluate all complaints to determine whether an investigation is necessary.
  • Establish and maintain procedures for implementing corrective and preventive actions (CAPA). Here the company was singled out for a lack of documentation. The firm’s Dec. 12 response was deemed inadequate by the FDA.
  • Establish and maintain acceptance procedures for verifying the device design.

FDAlogoSailing to the land of the original cherry blossoms and the birthplace of the Sumo Wrestler, the FDA hit Japan’s Eiken Chemical with a March 13 warning letter. It got off to a bad start with the FDA by failing to get Premarket Approval (PMA) for its fecal occult blood testing devices.

Eiken was also told it didn’t adequately validate device design, and properly handle complaints.

Closer to home, Canadian firm Safecross First Aid, manufacturers of first aid kits and their components, was accused in a March 26 warning letter of misbranding. It was also hit for failure to develop, maintain and implement written Medical Device Reporting (MDR) procedures.

It’s also worth noting that Safecross fell victim to the FDA’s “if it’s not documented, it didn’t happen” mantra. The warning letter chastised the company for failure to establish procedures for quality audits and ensure their effectiveness. According to the warning letter, Safecross’s Quality Manager said the firm had conducted certain quality audits.  However, FDA said the company had not documented dates or results of the audits.

In FDA speak, that means they don’t count, whether they happened or not.
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FDA 483s: We Read'em So You Don't Have To
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FDA 483s: We Read'em So You Don't Have To
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The FDA is taking its act overseas – and isn’t liking some of what it found. The latest batch of 483s has a decidely international flair: Italy, Japan and Canada had the pleasure of hosting FDA inspectors in recent months.
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