Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
18 Apr 2013
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Ivan E Reyes, Courtney R Tiegs
18 Apr 2013
21 CFR 111.83(b)(4)
Reserve sample - twice the quantity
Cited by Ivan E Reyes, Courtney R Tiegs
18 Apr 2013
21 CFR 111.503
Written procedures - returned dietary supplement
Cited by Ivan E Reyes, Courtney R Tiegs
18 Apr 2013
21 CFR 111.553
Written procedures - product complaint
Cited by Ivan E Reyes, Courtney R Tiegs
Inspected site
CLCocoKefir, LLCMedina, United States
Inspection team
CRCourtney R Tiegs
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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