Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2013-04-18.
At a glance
Inspections
2
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Apr 2013 – 18 Apr 2013 | Foods & Cosmetics | 483 | View 483 → |
| 15 May 2012 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
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
15 May 2012
21 CFR 111.12(b)
Personnel - quality control operations
Cited by Courtney R Tiegs, Dacia E Quick
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.430(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | 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 111.75(a)(2)(ii)(B) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CocoKefir, LLC's 2 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat