Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
12 Apr 2013
21 CFR 111.20(d)
Physical plant - design and construction
Cited by Jessica M Monteiro, Raymond L Cheung, Dhaval H Patel
12 Apr 2013
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Jessica M Monteiro, Raymond L Cheung, Dhaval H Patel
12 Apr 2013
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Jessica M Monteiro, Raymond L Cheung, Dhaval H Patel
12 Apr 2013
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Jessica M Monteiro, Raymond L Cheung, Dhaval H Patel
12 Apr 2013
21 CFR 111.80(a)
Components packaging, labels received
Cited by Jessica M Monteiro, Raymond L Cheung, Dhaval H Patel
Inspected site
NLNutraBio Labs, Inc.Middlesex, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.80(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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