Overview
- 12 public-safe observations are available for this inspection.
- 12 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.
16 Mar 2018
21 CFR 111.15(b)(1)
Physical plant - clean and sanitary
Cited by Sondra L Phillips, Alphonso A Haupt
16 Mar 2018
21 CFR 111.15(c)(3)
Cleaning compounds and toxic materials - holding
Cited by Sondra L Phillips, Alphonso A Haupt
16 Mar 2018
21 CFR 111.15(f)(3)
Plumbing - source of contamination
Cited by Sondra L Phillips, Alphonso A Haupt
16 Mar 2018
21 CFR 111.205(b)(2)
Master manufacturing record - controls, procedures
Cited by Sondra L Phillips, Alphonso A Haupt
16 Mar 2018
21 CFR 111.27(a)
Equipment - design - suitable
Cited by Sondra L Phillips, Alphonso A Haupt
Inspected site
NLNexagen, LLCFayetteville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.15(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(f)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(3)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.465(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 12 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