Overview
- 27 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
3 May 2017
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Robin N Goins
3 May 2017
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Robin N Goins
3 May 2017
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Robin N Goins
Inspected site
FIForYou, IncorporatedLoris, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 27 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