Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
14 Oct 2016
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Ivan E Reyes, Colleen M Aspinwall
14 Oct 2016
21 CFR 606.65(e)
Following manufacturer's instructions
Cited by Ivan E Reyes, Colleen M Aspinwall
14 Oct 2016
21 CFR 630.10(e)(2)
Additional Medical Assessment Factors
Cited by Ivan E Reyes, Colleen M Aspinwall
Inspected site
GBGrifols Bio Supplies IncMiami, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.5(d) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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