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.
4 Feb 2013
21 CFR 111.70(a)
Specifications - manufacturing process
Cited by Meredith M Cobb, Ashley Segura
4 Feb 2013
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Meredith M Cobb, Ashley Segura
4 Feb 2013
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Meredith M Cobb, Ashley Segura
4 Feb 2013
21 CFR 111.105
Ensure quality; package, labeled, master record
Cited by Meredith M Cobb, Ashley Segura
Inspected site
OCOLAAX Corp.Bartow, United States
Inspection team
MMMeredith M Cobb
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.430(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(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 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | 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 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