Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
10 May 2022
21 CFR 111.15(b)(2)
Physical plant - repair
Cited by Marinee Flores-Marrero, Benita C Okeke
10 May 2022
21 CFR 111.260(g)
Batch record - results; monitoring
Cited by Marinee Flores-Marrero, Benita C Okeke
10 May 2022
21 CFR 111.315(d)
Standard reference materials; criteria for selecting
Cited by Marinee Flores-Marrero, Benita C Okeke
10 May 2022
21 CFR 111.83(b)(1)
Reserve sample -container-closure system
Cited by Marinee Flores-Marrero, Benita C Okeke
Inspected site
ANAmerican Natural Products, Inc.Miami, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.15(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 observations
The full inspection record, as Atlas holds it, 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