Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
17 Dec 2015
21 CFR 111.20(c)(2)
Physical plant - material review and disposition
Cited by Laurissa S Flowers, Tajah L Blackburn
17 Dec 2015
21 CFR 111.20(d)(1)(i)
Floors, walls, ceilings
Cited by Laurissa S Flowers, Tajah L Blackburn
17 Dec 2015
21 CFR 111.260(h)
Batch record - results; testing, examination; batch
Cited by Laurissa S Flowers, Tajah L Blackburn
17 Dec 2015
21 CFR 111.35(b)(1)(iii)
Equipment, utensils; maintaining, cleaning, sanitizing
Cited by Laurissa S Flowers, Tajah L Blackburn
17 Dec 2015
21 CFR 111.365(a)
Conditions, controls -protect; microorganisms, contamination
Cited by Laurissa S Flowers, Tajah L Blackburn
Inspected site
NLNutravail, LLC.Chantilly, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.20(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(d)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(d) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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