Overview
- 8 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
27 Sep 2024
21 CFR 211.110(b)
In-process materials specifications
Cited by Kham Phommachanh, Wenzheng Zhang, Pearl C Ozuruigbo
27 Sep 2024
21 CFR 211.165(a)
Testing and release for distribution
Cited by Kham Phommachanh, Wenzheng Zhang, Pearl C Ozuruigbo
27 Sep 2024
21 CFR 211.170(b)
Drug product reserve containers
Cited by Kham Phommachanh, Wenzheng Zhang, Pearl C Ozuruigbo
27 Sep 2024
21 CFR 211.182
Personnel dating/signing equipment log
Cited by Kham Phommachanh, Wenzheng Zhang, Pearl C Ozuruigbo
27 Sep 2024
21 CFR 211.184(c)
Individual inventory record
Cited by Kham Phommachanh, Wenzheng Zhang, Pearl C Ozuruigbo
Inspected site
FFFuture Foam, Inc.San Clemente, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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