Intersect ENT, INC.
Form 483 issued November 3, 2017 · Menlo Park, California
- Inspection
- Oct 30 – Nov 3, 2017
- Investigators
- Chengjiu Hu· Lucila B. Nwatu
- Observations
- 4
- Pages
- 5
- FEI number
- 3008301917
In short: On November 3, 2017, FDA issued a Form 483 with 4 observations to Intersect ENT, INC. in Menlo Park, California (FEI 3008301917) after an inspection that ran Oct 30 – Nov 3, 2017. The investigators were Chengjiu Hu and Lucila B. Nwatu. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
The batch production and control records are deficient in that they do not include documentation of…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Employees engaged in the manufacture, processing and packing of a drug product lack the training required…
This inspection in context
Chengjiu Hu
1 document · 2017
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in California.
The firmIntersect ENT, INC. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intersect ENT, INC.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Intersect ENT, INC.?
Chengjiu Hu and Lucila B. Nwatu are named on this Form 483, for the inspection of Oct 30 – Nov 3, 2017. Each investigator has a profile showing what they cite most.
When was Intersect ENT, INC. inspected by FDA?
The inspection ran Oct 30 – Nov 3, 2017, and the Form 483 is dated November 3, 2017.
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.