Overview
- 7 public-safe observations are available for this inspection.
- 7 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 Apr 2014
21 CFR 211.28(a)
Clothing appropriate for duties performed
Cited by Linda F Murphy, Zachery L Miller
2 Apr 2014
21 CFR 211.42(c)(10)(vi)
Equipment to control conditions
Cited by Linda F Murphy, Zachery L Miller
2 Apr 2014
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Linda F Murphy, Zachery L Miller
2 Apr 2014
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Linda F Murphy, Zachery L Miller
Inspected site
SPSCA Pharmaceuticals, Inc.Little Rock, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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