Overview
- 12 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
25 Feb 2016
21 CFR 111.113(a)(1)
QC production, process control; material review, disposition
Cited by Kimberly M Lichter
25 Feb 2016
21 CFR 111.113(a)(1)
QC production, process control; material review, disposition
Cited by Kimberly M Lichter
25 Feb 2016
21 CFR 111.113(a)(2)
QC master manufacturing record; material review, disposition
Cited by Kimberly M Lichter
25 Feb 2016
21 CFR 111.113(a)(2)
QC master manufacturing record; material review, disposition
Cited by Kimberly M Lichter
25 Feb 2016
21 CFR 111.210(h)(2)
Master manufacturing record - sampling, tests, examinations
Cited by Kimberly M Lichter
Inspected site
NLNatrol LLCSanta Fe Springs, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.113(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.113(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.260(h) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 123.11(c) | Cited across public-safe Form 483 observations | 2x |
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