Tenon Medical, Inc. ("Tenon" or the "Company") (NASDAQ:TNON), a company transforming care for patients suffering with certain sacroiliac joint disorders, announced today, the US Food and Drug Administration (FDA) concluded a full Quality System Inspection Technique (QSIT) Level 2 Inspection at Tenon Medical. The QSIT inspection, used to assess a medical device manufacturer's compliance with the Quality System Requirements (QSR) and related regulations, guides the FDA investigators in performing an efficient and effective inspection, focusing on all key elements of a firm's Quality Management System.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Observations are made when in the investigator's judgement, conditions or practices observed would indicate that the device has been adulterated or is being prepared, packed, or held under conditions whereby it may be come adulterated or rendered injurious to health.
At the conclusion of the inspection on November 1, 2023, the FDA investigator determined there was no need to issue Form 483 and the Closing Meeting was completed with no observations or objectionable conditions identified. A final report will be issued to the Company over the coming weeks.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.