Overview
- 4 public-safe observations are available for this inspection.
- 4 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 Feb 2015
21 CFR 111.55
Production, process controls - implement
Cited by Peter T Erlandson, Katherine A Clarke Girolamo
10 Feb 2015
21 CFR 111.70(c)(2)
Specifications identity, purity strength, composition
Cited by Peter T Erlandson, Katherine A Clarke Girolamo
10 Feb 2015
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Peter T Erlandson, Katherine A Clarke Girolamo
10 Feb 2015
21 CFR 111.75(c)
Specifications met - verify; finished batch
Cited by Peter T Erlandson, Katherine A Clarke Girolamo
Inspected site
SPStandard Process, Inc.Palmyra, United States
Inspection team
KAKatherine A Clarke Girolamo
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.55 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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