Overview
- 10 public-safe observations are available for this inspection.
- 10 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.
22 Jul 2011
21 CFR 820.20(a)
Management ensuring quality policy is understood
Cited by Sean T Creighton, Thomas A Peter, Gary D Urbiel Goldner
22 Jul 2011
21 CFR 820.30(c)
Design input - Lack of or inadequate procedures
Cited by Sean T Creighton, Thomas A Peter, Gary D Urbiel Goldner
22 Jul 2011
21 CFR 820.30(d)
Design output - Lack of or inadequate procedures
Cited by Sean T Creighton, Thomas A Peter, Gary D Urbiel Goldner
22 Jul 2011
21 CFR 820.30(g)
Design validation - user needs and intended uses
Cited by Sean T Creighton, Thomas A Peter, Gary D Urbiel Goldner
22 Jul 2011
21 CFR 820.72(a)
Equipment suitability & capability
Cited by Sean T Creighton, Thomas A Peter, Gary D Urbiel Goldner
Inspected site
ZIZimmer, Inc.Warsaw, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | 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 10 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