Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
9 Mar 2012
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Matthew R Dionne, Steven C Madzo
9 Mar 2012
21 CFR 211.160(b)(4)
Instruments, apparatus, et. al. not meeting specs
Cited by Matthew R Dionne, Steven C Madzo
9 Mar 2012
21 CFR 211.192
Written record of investigation incomplete
Cited by Matthew R Dionne, Steven C Madzo
9 Mar 2012
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Matthew R Dionne, Steven C Madzo
Inspected site
NLNelson Laboratories, LLCSalt Lake City, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 5 observations
The source PDF and 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