Overview
- 9 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.
10 Sep 2013
21 CFR 111.27(a)
Equipment - design - suitable
Cited by Joel D Hustedt, Kimberly W Destromp
10 Sep 2013
21 CFR 111.70(e)
Specifications - contamination limits
Cited by Joel D Hustedt, Kimberly W Destromp
10 Sep 2013
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Joel D Hustedt, Kimberly W Destromp
10 Sep 2013
21 CFR 111.73
Specifications met - received product identified
Cited by Joel D Hustedt, Kimberly W Destromp
10 Sep 2013
21 CFR 111.75(c)(3)
Specifications met identity,purity, strength, comp; basis
Cited by Joel D Hustedt, Kimberly W Destromp
Inspected site
SPStandard Process, Inc.Palmyra, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.210(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.355 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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