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.
21 Jun 2010
21 CFR 111.103
Written procedures - quality control operations
Cited by Justine Tomasso, Doreen P Gubbay
21 Jun 2010
21 CFR 111.135
Quality control operations - product complaints; investigate
Cited by Justine Tomasso, Doreen P Gubbay
21 Jun 2010
21 CFR 111.553
Written procedures - product complaint
Cited by Justine Tomasso, Doreen P Gubbay
21 Jun 2010
21 CFR 111.560(b)
Quality control, review, approve; investigate, follow-up
Cited by Justine Tomasso, Doreen P Gubbay
Inspected site
APAspire Pharmaceuticals, Inc.Somerset, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.135 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(b) | 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 4 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