Overview
- 1 public-safe observation is available for this inspection.
- 1 structured CFR citation is represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
1 Oct 2009
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Nicholas P Diorio, Bruce H Mccullough
Inspected site
SPSage Products, LLCCary, United States
Inspection team
BHBruce H Mccullough
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
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- 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