Overview
- 9 public-safe observations are available for this inspection.
- 9 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 Jul 2013
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Edith M Gonzalez, Isabel Y Espinosa
9 Jul 2013
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Edith M Gonzalez, Isabel Y Espinosa
9 Jul 2013
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Edith M Gonzalez, Isabel Y Espinosa
9 Jul 2013
21 CFR 211.82(a)
Examination on receipt, before acceptance
Cited by Edith M Gonzalez, Isabel Y Espinosa
9 Jul 2013
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Edith M Gonzalez, Isabel Y Espinosa
Inspected site
NMNavajo Manufacturing CompanyDenver, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.82(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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