Overview
- 18 public-safe observations are available for this inspection.
- 18 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.
15 May 2012
21 CFR 111.12(b)
Personnel - quality control operations
Cited by Courtney R Tiegs, Dacia E Quick
15 May 2012
21 CFR 111.12(c)
Personnel - education, training, experience
Cited by Courtney R Tiegs, Dacia E Quick
15 May 2012
21 CFR 111.25(a)
Procedures - calibrating instruments
Cited by Courtney R Tiegs, Dacia E Quick
15 May 2012
21 CFR 111.70(a)
Specifications - manufacturing process
Cited by Courtney R Tiegs, Dacia E Quick
15 May 2012
21 CFR 111.70(c)(2)
Specifications identity, purity strength, composition
Cited by Courtney R Tiegs, Dacia E Quick
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 111.12(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 111.535(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 111.70(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)(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 |
Full 483 report
Get the verbatim text of all 18 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