Overview
- 19 public-safe observations are available for this inspection.
- 19 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.
28 Jun 2010
21 CFR 108.25(c)(2)
Process filing
Cited by Valerie A Potopsingh, Sarah A Wangseng, Amber D Brodas
28 Jun 2010
21 CFR 108.25(e)
Recall procedures
Cited by Valerie A Potopsingh, Sarah A Wangseng, Amber D Brodas
28 Jun 2010
21 CFR 110.10(b)(1)
Suitable outer garments
Cited by Valerie A Potopsingh, Sarah A Wangseng, Amber D Brodas
28 Jun 2010
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Valerie A Potopsingh, Sarah A Wangseng, Amber D Brodas
28 Jun 2010
21 CFR 110.10(b)(8)
Personal food/drink/tobacco
Cited by Valerie A Potopsingh, Sarah A Wangseng, Amber D Brodas
Inspected site
SISirob Imports, Inc.Lindenhurst, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 108.25(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 108.25(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(f) | 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(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 19 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