Overview
- 28 public-safe observations are available for this inspection.
- 14 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.
13 May 2015
21 CFR 110.80(a)(7)
Receipt/storage - liquid and dry raw materials
Cited by Kevin A Beavers, Lisa L Flores
13 May 2015
21 CFR 110.80(a)(7)
Receipt/storage - liquid and dry raw materials
Cited by Kevin A Beavers, Lisa L Flores
13 May 2015
21 CFR 111.103
Written procedure quality control operations material review
Cited by Kevin A Beavers, Lisa L Flores
Inspected site
TCTeeter Creek Herbs, IncAva, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.20(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(a)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.180(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.255(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.260(h) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.70(c)(2) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 28 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