Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
19 Jul 2016
21 CFR 111.123(b)(2)
Quality control - batch, product specifications
Cited by Ashar P Parikh, James C Lee
19 Jul 2016
21 CFR 111.12(c)
Personnel - education, training, experience
Cited by Ashar P Parikh, James C Lee
19 Jul 2016
21 CFR 111.260(k)(1)
Batch record - identifier; labels
Cited by Ashar P Parikh, James C Lee
19 Jul 2016
21 CFR 111.27(a)(5)(i)
Refrigerator, freezer - temperature recording device
Cited by Ashar P Parikh, James C Lee
19 Jul 2016
21 CFR 111.303
Written procedures - tests, examinations; specifications met
Cited by Ashar P Parikh, James C Lee
Inspected site
APAll Points Manufacturing, LLC.Vallejo, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.123(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(k)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(5)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.303 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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