Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
11 Dec 2013
21 CFR 111.70(b)(3)
Specifications - contamination limits
Cited by Kevin A Beavers, Audra J Lenhart
11 Dec 2013
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Kevin A Beavers, Audra J Lenhart
11 Dec 2013
21 CFR 111.75(b)(2)
Specifications met - deviation, unanticipated occurrence
Cited by Kevin A Beavers, Audra J Lenhart
11 Dec 2013
21 CFR 111.205(b)(1)
Master manufacturing record - specifications; quality
Cited by Kevin A Beavers, Audra J Lenhart
11 Dec 2013
21 CFR 111.205(b)(2)
Master manufacturing record - controls, procedures
Cited by Kevin A Beavers, Audra J Lenhart
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 111.205(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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