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.
29 May 2025
21 CFR 111.120(b)
Quality control operations - specifications; components, packaging, labels
Cited by Siobhan G Taylor, Courtney E Hillier, Hassan M Fakhreddine
29 May 2025
21 CFR 111.123(a)(7)
Quality control operations - finished batch, specifications
Cited by Siobhan G Taylor, Courtney E Hillier, Hassan M Fakhreddine
29 May 2025
21 CFR 111.210
Master manufacturing record - record requirements
Cited by Siobhan G Taylor, Courtney E Hillier, Hassan M Fakhreddine
29 May 2025
21 CFR 111.260
Batch record - required information
Cited by Siobhan G Taylor, Courtney E Hillier, Hassan M Fakhreddine
29 May 2025
21 CFR 111.70(b)
Specifications - components
Cited by Siobhan G Taylor, Courtney E Hillier, Hassan M Fakhreddine
Inspected site
FPFuture Pak LLCWixom, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(g) | 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