Overview
- 4 public-safe observations are available for this inspection.
- 4 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 Mar 2020
21 CFR 820.70(d)
Implementing Personnel Procedures, Health, Cleanliness.
Cited by Gregson A Joseph
3 Mar 2020
21 CFR 820.80(c)
Lack of or inadequate In-process acceptance procedures
Cited by Gregson A Joseph
3 Mar 2020
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by Gregson A Joseph
Inspected site
EIEuromed, Inc.Orangeburg, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | 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 4 observations
The source PDF, 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