Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
9 Sep 2015
21 CFR 114.100(a)
Raw materials, packaging, finished product
Cited by Dana M Lewis, Paul E Frazier
9 Sep 2015
21 CFR 114.100(b)
Maintenance of processing and production records
Cited by Dana M Lewis, Paul E Frazier
Inspected site
BOBest of TexasDetroit, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 108.25(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.83 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 114.89 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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