Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
23 Apr 2018
21 CFR 589.2001(c)(3)(i)
Records:establish, maintain, make available
Cited by Heather A Mccauley, Christopher D Snyder, Jason D Werne
23 Apr 2018
21 CFR 507.19(b)
Sanitation
Cited by Heather A Mccauley, Christopher D Snyder, Jason D Werne
23 Apr 2018
21 CFR 507.202(a)
Record Requirements
Cited by Heather A Mccauley, Christopher D Snyder, Jason D Werne
23 Apr 2018
21 CFR 507.25(a)
Plant Operations
Cited by Heather A Mccauley, Christopher D Snyder, Jason D Werne
23 Apr 2018
21 CFR 507.25(b)(1)
Raw Material Controls
Cited by Heather A Mccauley, Christopher D Snyder, Jason D Werne
Inspected site
MAMIG Acquisition DBA Erie International GroupPainesville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 507.19(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.202(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 507.25(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 589.2001(c)(3)(i) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
The full inspection record, as Atlas holds it, 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