Overview
- 4 public-safe observations are available for this inspection.
- 2 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.
16 Jun 2017
21 CFR 111.260(d)
Batch record - component; unique identifier
Cited by Monica M Mcclure, Nicole C Mayfield
16 Jun 2017
21 CFR 111.260(d)
Batch record - component; unique identifier
Cited by Monica M Mcclure, Nicole C Mayfield
16 Jun 2017
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Monica M Mcclure, Nicole C Mayfield
16 Jun 2017
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Monica M Mcclure, Nicole C Mayfield
Inspected site
AFAncient Formulas, Inc.Wichita, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.260(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 2x |
Full 483 report
Get the verbatim text of all 4 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