Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
21 Feb 2020
21 CFR 111.140(b)(1)
Records - quality control operations; responsibilities
Cited by Kunapuli T Madhusudhan
21 Feb 2020
21 CFR 111.165(b)
Product received - visually examine invoice, guarantee, cert
Cited by Kunapuli T Madhusudhan
21 Feb 2020
21 CFR 111.475(b)(1)
Written procedures - holding; distributing
Cited by Kunapuli T Madhusudhan
21 Feb 2020
21 CFR 111.535(b)(1)
Records - returned dietary supplement: written procedures
Cited by Kunapuli T Madhusudhan
Inspected site
FIForYou, IncorporatedLoris, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.14(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
The full inspection record, as Atlas holds it, 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