Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
3 Jun 2011
21 CFR 111.25(a)
Procedures - calibrating instruments
Cited by Samantha J Pinizzotto, Michael H Tollon
3 Jun 2011
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Samantha J Pinizzotto, Michael H Tollon
3 Jun 2011
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Samantha J Pinizzotto, Michael H Tollon
3 Jun 2011
21 CFR 111.77(a)
Specifications not met - reject, quality control
Cited by Samantha J Pinizzotto, Michael H Tollon
3 Jun 2011
21 CFR 111.90(c)
Reprocessed batch - quality control approve
Cited by Samantha J Pinizzotto, Michael H Tollon
Inspected site
ILIon Labs Inc.Largo, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j) | 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 111.77(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.90(c) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 observations
The source PDF and 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