Overview
- 9 public-safe observations are available for this inspection.
- 9 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
17 Jul 2013
21 CFR 111.73
Specifications met - component identity
Cited by Eric Rothschild, Liatte Krueger, Melba T Rivera Clavell
17 Jul 2013
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Eric Rothschild, Liatte Krueger, Melba T Rivera Clavell
17 Jul 2013
21 CFR 111.105(i)
QC - required operations returned dietary supplements
Cited by Eric Rothschild, Liatte Krueger, Melba T Rivera Clavell
17 Jul 2013
21 CFR 111.120(b)
QC operations -specifications; components, packaging, labels
Cited by Eric Rothschild, Liatte Krueger, Melba T Rivera Clavell
17 Jul 2013
21 CFR 111.123(a)(7)
Quality control operations - finished batch, specifications
Cited by Eric Rothschild, Liatte Krueger, Melba T Rivera Clavell
Inspected site
WHWindmill Health Products, LLCWest Caldwell, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.127(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.73 | 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