Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
17 Jan 2018
21 CFR 120.24(a)
Process controls - HACCP plan - 5 log reduction
Cited by Yuyan Liang, Tracy M Portelli
17 Jan 2018
21 CFR 120.11(a)(1)(iv)
Records - not signed and dated by qualified individual
Cited by Yuyan Liang, Tracy M Portelli
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 120.11(a)(1)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.24(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.6(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 120.8(b)(1) | Cited across public-safe Form 483 observations | 1x |
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