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.
9 Mar 2016
21 CFR 111.20(c)(3)
Physical plant - separate areas for products
Cited by Yuyan Liang, Meredith P Soehl
9 Mar 2016
21 CFR 111.75(a)(1)(i)
Component - verify identity, dietary ingredient
Cited by Yuyan Liang, Meredith P Soehl
9 Mar 2016
FDCA 761(b)(1)
No label copy submitted with AE report (dietary supplement)
Cited by Yuyan Liang, Meredith P Soehl
Inspected site
APAJES Pharmaceuticals, LLCCopiague, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.20(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.605 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b)(3) | Cited across public-safe Form 483 observations | 1x |
| FDCA 761(b)(1) | 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