Overview
- 39 public-safe observations are available for this inspection.
- 11 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.
27 Jun 2019
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Miaja Umaedi, Trang N Cox
27 Jun 2019
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Miaja Umaedi, Trang N Cox
Inspected site
AMAFP ManufacturingEdgewater, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 39 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