Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
4 Jan 2012
21 CFR 110.10(b)(6)
Effective use of hair restraint
Cited by Jennifer Lalama, Michael C Lombardi, Kelly M Byers
4 Jan 2012
21 CFR 110.40(a)
Materials and workmanship
Cited by Jennifer Lalama, Michael C Lombardi, Kelly M Byers
4 Jan 2012
21 CFR 110.80(a)(5)
Holding in bulk or suitable containers
Cited by Jennifer Lalama, Michael C Lombardi, Kelly M Byers
Inspected site
SISpicepak, Inc.Miami, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(13) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(6) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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