Simplifying Global Compliance
The QMN Weekly Bulletin
AngioDynamics Lacked Approval on Device Feature, 483 States
Aug. 17, 2012
A Form 483 for AngioDynamics of Queensbury, N.Y., states the company distributed a range of devices with flaws or unapproved features. The 12-observation Form 483 was issued at the conclusion of an inspection that stretched from Nov. 14, 2011, to Feb. 10 of this year. For example, the FDA had informed AngioDynamics that a soft tissue ablation tool made by the company could only be cleared if one feature was removed. The company removed the feature but allowed previously distributed products to remain on the market with the feature intact. In another instance, the company discovered during a premarket visual inspection that there was a hairline crack in the sheath of an infusion system but allowed it to go to market.
The GMP Letter
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