Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 Nov 2017
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Lucila B Nwatu, Chengjiu Hu
3 Nov 2017
21 CFR 211.188(b)
Batch production and Batch Control Record Requirements
Cited by Lucila B Nwatu, Chengjiu Hu
3 Nov 2017
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Lucila B Nwatu, Chengjiu Hu
3 Nov 2017
21 CFR 211.68(b)
Computer control of master formula records
Cited by Lucila B Nwatu, Chengjiu Hu
Inspected site
IEIntersect ENT, Inc.Menlo Park, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 4 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere