Overview
- 17 public-safe observations are available for this inspection.
- 15 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.
6 Aug 2010
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Justine M Corson, Ramon E Martinez, Rory Geyer
6 Aug 2010
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Justine M Corson, Ramon E Martinez, Rory Geyer
6 Aug 2010
21 CFR 314.81(b)(1)(ii)
Contamination, chemical or physical change, deterioration
Cited by Justine M Corson, Ramon E Martinez, Rory Geyer
6 Aug 2010
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Justine M Corson, Ramon E Martinez, Rory Geyer
6 Aug 2010
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Justine M Corson, Ramon E Martinez, Rory Geyer
Inspected site
FMFresenius Medical Care Holdings, Inc.Waltham, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 17 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