Overview
- 11 public-safe observations are available for this inspection.
- 11 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
26 Mar 2018
21 CFR 111.205(b)(1)
Master manufacturing record-specifications; packaged, label
Cited by Matthew A Kozler, Felicia M Orlando, Janice L Straight
26 Mar 2018
21 CFR 111.255(b)
Batch record - complete
Cited by Matthew A Kozler, Felicia M Orlando, Janice L Straight
26 Mar 2018
21 CFR 111.27(d)
Equipment - maintain - general
Cited by Matthew A Kozler, Felicia M Orlando, Janice L Straight
26 Mar 2018
21 CFR 111.605
Records - keep: 1 year, 2 years
Cited by Matthew A Kozler, Felicia M Orlando, Janice L Straight
26 Mar 2018
21 CFR 111.70(b)(3)
Specifications - contamination limits
Cited by Matthew A Kozler, Felicia M Orlando, Janice L Straight
Inspected site
APAvalon Packaging, Inc.Orem, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.410(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.605 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | 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(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 11 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