The FDA has warned Arnold Tuber Industries, DBA Sci-Dent, that its aspirating dental syringes violate the law, because the company doesn't have approval to market them and is not maintaining adequate records on them.
The company doesn't have adequate procedures to investigate ways in which the needles have failed -- such as hubs that fall off -- and it doesn't have documents showing quality control, the agency charges in the Nov. 30 warning letter, which followed July inspections.
Sci-Dent could not be reached for comment.
The FDA gave the company 15 days to explain how it would come into compliance and threatened such actions as seizure, injunction and penalties if it doesn't.
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