Overview
- 6 public-safe observations are available for this inspection.
- 3 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.
8 Jun 2015
21 CFR 606.140(b)
Provisions to monitor lab test procedures & instruments
Cited by Juan R Jimenez Garcia
8 Jun 2015
21 CFR 606.140(b)
Provisions to monitor lab test procedures & instruments
Cited by Juan R Jimenez Garcia
Inspected site
AMAlbany Medical Center HospitalAlbany, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.260(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.140(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.60(b) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 6 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