Overview
- 15 public-safe observations are available for this inspection.
- 15 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.
2 Jul 2012
21 CFR 111.30(c)
Equipment - automated - calibrate, inspect
Cited by Joel D Hustedt, Catherine M Hollman
2 Jul 2012
21 CFR 111.65
Quality control - quality, dietary supplement
Cited by Joel D Hustedt, Catherine M Hollman
2 Jul 2012
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Joel D Hustedt, Catherine M Hollman
2 Jul 2012
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Joel D Hustedt, Catherine M Hollman
Inspected site
SPStandard Process, Inc.Palmyra, United States
Inspection team
CMCatherine M Hollman
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.15(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.155(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.605(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | 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 15 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