Overview
- 18 public-safe observations are available for this inspection.
- 18 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.
29 Mar 2012
21 CFR 111.27(b)
Instruments - calibration
Cited by Dennis R Hock, Katelyn A Staub-Zamperini, Mary R Kirker
29 Mar 2012
21 CFR 111.35(b)(2)
Document-equipment date of use, maintain, clean, sanitize
Cited by Dennis R Hock, Katelyn A Staub-Zamperini, Mary R Kirker
29 Mar 2012
21 CFR 111.55
Production, process controls - packaged, labeled
Cited by Dennis R Hock, Katelyn A Staub-Zamperini, Mary R Kirker
29 Mar 2012
21 CFR 111.70(a)
Specifications - manufacturing process
Cited by Dennis R Hock, Katelyn A Staub-Zamperini, Mary R Kirker
29 Mar 2012
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Dennis R Hock, Katelyn A Staub-Zamperini, Mary R Kirker
Inspected site
MIMADE Inc.Oakmont, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.55 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(a) | 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 18 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