Intersect ENT, INC.
Form 483 issued March 6, 2019 · Menlo Park, California
- Inspection
- Feb 27 – Mar 6, 2019
- Observations
- 4
- Pages
- 4
- FEI number
- 3008301917
In short: On March 6, 2019, FDA issued a Form 483 with 4 observations to Intersect ENT, INC. in Menlo Park, California (FEI 3008301917) after an inspection that ran Feb 27 – Mar 6, 2019. Most observations concern quality system and packaging & labeling.
At a glance
3 of 4 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Strict control is not exercised over labeling issued for use in…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug…
- 04
Employees are not given training in the particular operations they perform as part of their function…
This inspection in context
Questions about this 483
What did FDA find at Intersect ENT, INC.?
FDA listed 4 observations on this Form 483, mostly about quality system and packaging & labeling. The opening words of each observation are shown on this page.
When was Intersect ENT, INC. inspected by FDA?
The inspection ran Feb 27 – Mar 6, 2019, and the Form 483 is dated March 6, 2019.
How do I get the full Form 483 for Intersect ENT, INC.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.