Overview
- 6 public-safe observations are available for this inspection.
- 5 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 Feb 2013
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Audra J Lenhart, Brian R Cronenwett
11 Feb 2013
21 CFR 111.95(b)(1)
Records - established specifications
Cited by Audra J Lenhart, Brian R Cronenwett
11 Feb 2013
21 CFR 111.205(a)
Master manufacturing record - each batch
Cited by Audra J Lenhart, Brian R Cronenwett
11 Feb 2013
21 CFR 111.205(a)
Master manufacturing record - unique formulation
Cited by Audra J Lenhart, Brian R Cronenwett
11 Feb 2013
21 CFR 111.210(d)
Master manufacturing record - Supplemental Facts
Cited by Audra J Lenhart, Brian R Cronenwett
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(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | 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 111.95(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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