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The latest batch of Food and Drug Administration (FDA) inspection letters noting objectionable conditions, aka 483s, has a decidedly international flair: Italy, Japan, and Canada had the pleasure of hosting FDA inspectors in recent months. Three firms were found wanting by the agency in a number of areas.
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In the land of Christopher Columbus’s youth 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, 2013, warning letter for failing in several current good manufacturing practices (cGMP) areas. The FDA inspector cited the manufacturer’s 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, 2012, response was deemed inadequate by the FDA.
• Establish and maintain acceptance procedures for verifying the device design.
Sailing 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, 2013, warning letter. The company 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, 2013, 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, the FDA said the company had not documented the audit dates or results. In FDA-speak, that means the audits didn’t count, whether they happened or not.
This article first appeared in the April 17, 2013, issue of AssurXblog.
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Comments
A few points
One: Were some Accrediation Bodies less money-minded and more professionally-oriented, the registered Companies would perform better. Two: Were the registered Companies less budget- or tax-concerned, they would perform better. Three: Were FDA less lobbysm-oriented, USA's foreign Suppliers would perform better. Bad events are what they are, there's no excuse; but, at the same time, to prevent bad events, we have to dig deep into their causes: reading of them on newspapers' first page is far from solving the problems. Thank you.
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