Overview
- 10 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
11 Dec 2008
21 CFR 803.50(a)(2)
Report of Malfunction
Cited by Kimberly Lewandowski-Walker, James W Plucinski, Joseph A Morkunas, Karen E Masley-Joseph
11 Dec 2008
21 CFR 820.20
Management responsibility
Cited by Kimberly Lewandowski-Walker, James W Plucinski, Joseph A Morkunas, Karen E Masley-Joseph
11 Dec 2008
21 CFR 820.30(f)
Design verification procedures
Cited by Kimberly Lewandowski-Walker, James W Plucinski, Joseph A Morkunas, Karen E Masley-Joseph
11 Dec 2008
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Kimberly Lewandowski-Walker, James W Plucinski, Joseph A Morkunas, Karen E Masley-Joseph
11 Dec 2008
21 CFR 820.50(a)
Evaluation of suppliers, contractors, etc., requirements
Cited by Kimberly Lewandowski-Walker, James W Plucinski, Joseph A Morkunas, Karen E Masley-Joseph
Inspected site
ALAbbott LaboratoriesAbbott Park, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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