Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
12 Aug 2010
21 CFR 111.70(b)(1)
Specifications - component identity
Cited by Dhaval H Patel, Hitesh R Patel
12 Aug 2010
21 CFR 111.70(f)
Specifications - product received for packaging, labeling
Cited by Dhaval H Patel, Hitesh R Patel
12 Aug 2010
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Dhaval H Patel, Hitesh R Patel
12 Aug 2010
21 CFR 111.75(c)(1)
Specifications met - verify; production, process control
Cited by Dhaval H Patel, Hitesh R Patel
Inspected site
SPSoluble Products Co., LPLakewood, United States
Inspection team
HRHitesh R Patel
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(f) | 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 111.75(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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