Overview
- 13 public-safe observations are available for this inspection.
- 13 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.
24 Mar 2016
21 CFR 110.10(b)(6)
Effective use of hair restraint
Cited by Milan S Mcgorty, John E Aghadia, Michael R Dominick
24 Mar 2016
21 CFR 110.37(e)(2)
Hand cleaning and sanitizing preparations
Cited by Milan S Mcgorty, John E Aghadia, Michael R Dominick
24 Mar 2016
21 CFR 110.80
Reasonable precautions
Cited by Milan S Mcgorty, John E Aghadia, Michael R Dominick
24 Mar 2016
21 CFR 110.80(b)(7)
Equipment, containers, utensils
Cited by Milan S Mcgorty, John E Aghadia, Michael R Dominick
24 Mar 2016
21 CFR 123.11(b)
Sanitation monitoring
Cited by Milan S Mcgorty, John E Aghadia, Michael R Dominick
Inspected site
GTGMI Trading LLCSouth Plainfield, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(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 110.80 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(5) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 13 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