Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
25 Apr 2013
21 CFR 111.25(b)
Procedures - calibrating automated, mechanical equip
Cited by Jason D Tenney, Meredith M Cobb
25 Apr 2013
21 CFR 111.30(c)
Equipment - automated - calibrate, inspect
Cited by Jason D Tenney, Meredith M Cobb
25 Apr 2013
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Jason D Tenney, Meredith M Cobb
25 Apr 2013
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Jason D Tenney, Meredith M Cobb
25 Apr 2013
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Jason D Tenney, Meredith M Cobb
Inspected site
WMWe Make Vitamins LLCLakeland, United States
Inspection team
MMMeredith M Cobb
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.120(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.403 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(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)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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