Overview
- 43 public-safe observations are available for this inspection.
- 40 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
29 May 2014
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Laura B Kennedy, Brittany R Laymon, Kristen E Szenderski, Paul Z Balcer, Teena H Aiken
29 May 2014
21 CFR 110.20(b)(1)
Sufficient space
Cited by Laura B Kennedy, Brittany R Laymon, Kristen E Szenderski, Paul Z Balcer, Teena H Aiken
29 May 2014
21 CFR 110.20(b)(4)
Drip and condensate
Cited by Laura B Kennedy, Brittany R Laymon, Kristen E Szenderski, Paul Z Balcer, Teena H Aiken
29 May 2014
21 CFR 110.20(b)(4)
Floors, walls and ceilings
Cited by Laura B Kennedy, Brittany R Laymon, Kristen E Szenderski, Paul Z Balcer, Teena H Aiken
29 May 2014
21 CFR 110.20(b)(5)
Safety lighting and glass
Cited by Laura B Kennedy, Brittany R Laymon, Kristen E Szenderski, Paul Z Balcer, Teena H Aiken
Inspected site
SISixdog Investments, LLCWellington, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 118.4 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(3) | 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(b)(2) | 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 110.37(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.93 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.10(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.10(a)(3)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.10(a)(3)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.10(a)(3)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.10(a)(3)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.10(a)(3)(vii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(a)(2)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.4(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.5(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.6(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 118.9 | Cited across public-safe Form 483 observations | 1x |
| FDCA 402(a)(4) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 43 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