Intersect ENT, INC.
FDA inspection history in Menlo Park, California, 2017 to 2019
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Menlo Park, California.
- 2017The longest 483 on file: 4 observations over 5 pages at Menlo Park, California.
Cited most
Across all Intersect ENT observations on file
- 21 CFR 211.25Personnel qualifications2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.125Labeling issuance1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.198Complaint files1
The complete Intersect ENT file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Menlo Park, California
Two Form 483s · 2017 to 2019 · 8 observations
Latest: Form 483, Mar 6, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-03-06 | 483 Form 483 | Menlo Park, California | 4 | $99 |
| 2017-11-03 | 483 Form 483 | Menlo Park, California | 4 | $99 |
Investigators on these documents
FEI number 3008301917 · most recent document Mar 6, 2019
About Intersect ENT, INC.
How many FDA Form 483s has Intersect ENT, INC. received?
FDA Intel has 2 Form 483s on file for Intersect ENT, INC.; the most recent is dated Mar 6, 2019.
When was Intersect ENT, INC. last inspected by FDA?
The most recent FDA inspection document on file for Intersect ENT, INC. is a Form 483 dated Mar 6, 2019, for the site in Menlo Park, California.
What did FDA cite at Intersect ENT, INC.?
The regulations cited most in the observations on file for Intersect ENT, INC. are 21 CFR 211.25 (Personnel qualifications), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.125 (Labeling issuance), 1 time.