483
Dental Engineering Laboratories, LLCDental Engineering Laboratories, LLC – FDA 483, May 21, 2019
Record Details
An FDA inspection of Dental Engineering Laboratories, LLC in Santa Barbara, CA, revealed a significant quality system deficiency. The firm failed to establish a design history file for its Class II Terauchi File Retrieval Kit, a product that has been on the market since 2016. This indicates a lack of proper design control documentation for a medical device.
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