Overview
- 22 public-safe observations are available for this inspection.
- 11 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.
7 Apr 2017
21 CFR 111.140(b)(1)
QC ops; written procedures; material review, disposition
Cited by Robin N Goins, Adam J Williams
7 Apr 2017
21 CFR 111.140(b)(1)
QC ops; written procedures; material review, disposition
Cited by Robin N Goins, Adam J Williams
7 Apr 2017
21 CFR 111.205(b)(1)
Master manufacturing record - specifications; quality
Cited by Robin N Goins, Adam J Williams
Inspected site
NLNexagen, LLCFayetteville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.155(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.475(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.80(a) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 22 observations
Every observation in full, 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