Drug factory · FDA FEI 3008301917
Intersect ENT, Inc.
1555 Adams Dr, Menlo Park, CA, United States
No problems found at FDA's last inspection, Aug 7, 2025.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2011: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Mometasone | Makes it | Intersect ENT, Inc. | 10599-003 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 7, 2025 | No problems found | Drug Quality Assurance | — |
| Mar 6, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 11, 2012 | No problems found | Drug Quality Assurance | 2 |
| May 9, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 11, 2012 inspection
- Report of Death or Serious Injury 21 CFR 803.50(a)(1)
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury. - Investigation of device failures 21 CFR 820.198(c)
Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated, and investigated where necessary.
Registered with FDA for: manufacture.