Overview
- 19 public-safe observations are available for this inspection.
- 18 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.
19 May 2011
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Ashley N Williams, Adrian Rodriguez
19 May 2011
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Ashley N Williams, Adrian Rodriguez
19 May 2011
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Ashley N Williams, Adrian Rodriguez
19 May 2011
21 CFR 111.155(a)
Visually examine - containers
Cited by Ashley N Williams, Adrian Rodriguez
Inspected site
JNJW Nutritional LLCAllen, United States
Inspection team
ARAdrian Rodriguez
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.403 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.155(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.160(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.160(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 19 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