Overview
- 14 public-safe observations are available for this inspection.
- 14 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.
12 Apr 2011
21 CFR 111.27(a)(7)
Compressed air, gases
Cited by Katelyn A Staub-Zamperini, Mary R Kirker, Erica L Nicoll
12 Apr 2011
21 CFR 111.27(b)
Instruments - calibration
Cited by Katelyn A Staub-Zamperini, Mary R Kirker, Erica L Nicoll
12 Apr 2011
21 CFR 111.35(b)(2)
Document-equipment date of use, maintain, clean, sanitize
Cited by Katelyn A Staub-Zamperini, Mary R Kirker, Erica L Nicoll
12 Apr 2011
21 CFR 111.55
Production, process controls - implement
Cited by Katelyn A Staub-Zamperini, Mary R Kirker, Erica L Nicoll
12 Apr 2011
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Katelyn A Staub-Zamperini, Mary R Kirker, Erica L Nicoll
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 111.205(a) | 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(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(b) | 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 111.460(a) | 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 111.560(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
| FDCA 761(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 14 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